Vacancies at Adcock Ingram

MAIN TASKS / RESPONSIBILITIES:

• Perform new qualification protocols (OQ/PQ) for HVAC, facilities, utilities, and equipment to ensure functionality and compliance with SOPs.
• Conduct re-qualification per the Validation Master Plan (VMP) and ensure target dates are achieved.
• Prepare, review, and execute validation protocols and reports according to cGMP standards.
• Ensure validation documentation practices are aligned with AICC and QA compliance requirements.
• Coordinate multidisciplinary project teams by facilitating sessions, conducting risk analysis, initiating change controls, and tracking progress.
• Develop and maintain in-depth technical understanding of manufacturing processes and systems.
• Proactively communicate validation progress, risks, and issues with internal and external stakeholders.
• Support regulatory audits by preparing validation documentation and responding to queries.
• Identify, plan, and implement process improvement opportunities in validation and manufacturing systems.
• Gather, analyse, and present validation data to management for decision-making.

Requirements

• Qualifications Scientific or Technical qualification in Chemistry, Chemical Engineering, Biotechnology, or related discipline (essential).
• Postgraduate qualification in Quality Assurance, Validation, or Pharmaceutical Sciences – advantageous.
• Training in cGMP, GLP, and ISO/PIC/S requirements – advantageous.

Experience

• Minimum of 5 years’ experience in pharmaceutical manufacturing or sterile filling (essential).
• Proven on-the-job validation experience, including preparation and execution of validation protocols (essential).
• Previous laboratory working experience (advantageous).
• Experience in regulatory audit preparation and participation (SAHPRA, ISO, PIC/S).
• Exposure to continuous improvement initiatives and lean methodologies.

Languages

• English             

Other

• Ability to interpret engineering drawings and technical documentation.
• Strong computer literacy (MS Office, Excel, and validation/QA systems).
• Willingness to work extended hours or shifts during critical validation activities.
• Ability to manage multidisciplinary teams and facilitate cross-functional collaboration.
• High resilience and capability to perform under pressure.

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Key Performance areas : 

• Ensure timeous initiation and management of the registration process for new product submissions.
• Ensure approval of registration applications of all medicines with the relevant authorities:
• Completes specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s to the Regulatory Authority.
• Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations.
• Ensures that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreements.
• Ensure the maintenance/update of registrations in accordance with the relevant legislation, regulations and guidelines:
• Receives, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory Authority.
• Completes dossier audits of Registered Products for the assigned products.
• Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified time-lines in order to support the business and strategic company objectives.
• Establish and maintain effective relationships with Regulatory Authorities:
• Manages relationships with the Regulatory Authorities to ensure more effective streamlining of the company’s applications when required.
• Building sustainable relationships with internal and external stakeholders to achieve regulatory goals.
• Effectively managing, auditing and implementation of Regulatory systems.
• Prepare, review and adhere to Standard Operating Procedures (SOP’s) and local Regulatory Guidelines.
• Ensure alignment of personal and company values.

Technical Skills/ Compentencies Required : 

• Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
• Experience in use of eCTD software builder and compilation of eCTD application will be an advantage.

Behavioral skills and Attributes : 

• Strong detail, quality and compliance orientation.
• Sound project management capabilities.
• Time management.
• Strict adherence to the timelines.
• Analytical and problem-solving skills.
• Self-starter, able to work independently.
• Able to handle multiple projects simultaneously.
• Good verbal and written communication skills.
• Information seeking.
• Ability to understand stakeholder needs.
• Sense of urgency.
• Perform and succeed under pressure.
• Team player.
• Adaptability – Able to adapt to changes in the work environment.

Closing Date : 23 September 2026

Requirements

• Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council.
• 3 - 5 years’ experience in Regulatory Affairs, preferably in orthodox, human medicines.
• Demonstrable experience across the product development, commercialization and maintenance lifecycle.
• Sound project management capabilities.
• Proven ability to consistently deliver to quality, time and cost standards.

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Description

• Ensuring compliance with all the provisions of the Act 101 of 1965; Pharmacy Act, Act 53 of 1973 and all regulations and guidelines pertaining to the Wholesale license for medicinal products and Good Wholesaling/Distribution and Good Housekeeping Practices and Good Pharmacy Practice.
• Supervision of purchasing, acquiring, importing, keeping, possessing, using, releasing, storage, packaging, supplying or selling of any medicine or schedule substance or the supervision thereof.
• Compliance to national regulatory requirements (Act 101 of 1965; Pharmacy Act 53 of 1973, SAHPRA, PICS/WHO guidelines and OHS act) with respect to Quality Management Systems and current Good Distribution & Wholesaling Practices (cGDP/GWP).
• Establish an effective quality management system to support the Adcock Ingram Healthcare SAHPRA Licence.
• Ensure Standard Operating Procedures (SOP’s) are initiated, reviewed, approved and implemented
• Ensure that quality systems are implemented and comply with SAHPRA Guidelines.
• Review and approve Validation protocols and reports ensuring compliance with cGDP/GWP requirements.
• Maintain a satisfactory service level to Logistics Distribution.
• Lead quality review meetings with the involvement of the AIL RP and Managing Director to assess the effectiveness and applicability of the quality systems.
• Escalate non-compliance of the quality systems immediately to Executive Management where necessary and assist in addressing the non-compliance.
• Perform performance assessments of all direct reports against agreed objectives.
• Product Release (based on Applicant release)
• Audits (preparation and correcting any non-conformances found) and CAPA initiation and close-out
• Deviations and Non-conformance raising, monitoring and close-out. Raise, maintain and monitor deviations, non-conformances and CAPA’s.
• Supply and maintain S5 & S6 stock and Registers.
• Supply and maintain section 21 items.
• Assist with stock take.
• Dedicated storage area management (Damages, Quarantine, Returns, Cold Store & Schedule Stores).
• Management of reverse logistics (RETURNS).
• Pharmacovigilance reporting.
• Receipt, fine checking and sampling of 3rd party stock.
• Deputise the Responsible Pharmacist (RP) by performing all RP duties and accepting responsibility as stand in RP in the absence of the RP.
• Assisting the Responsible Pharmacist (RP) where required.
• Performing duties, tasks and reasonable instructions as delegated by the Responsible Pharmacist.
• Key holder to critical keys required for daily operations.
• After hours, call out in case of fridge failure or emergencies.
• Risk Assessments, initiate and lead Risk Assessment meetings with various personnel to understand occurrences and trends in quality, operations and distribution.
• Personal interaction in all critical regulatory interactions with SAHPRA; DOH and SAPC.
• Foster good working relationships with the health authorities, principals and internal customers.
• Participate in Marketing, Supply chain; Regulatory and Quality Assurance cross-functional teams.
• Inform all Pharmacists of Adcock Ingram Healthcare about current developments in the legislation and other developments regarding compliance with current Distribution Practices.
• Approve technical records and training.
• Ensure correct handling of recalled and quarantined stock.
• Ensure timely handling and reporting product complaints from within the warehouse or from external customers.
• Ensure continuous supervision of the wholesale or distributor pharmacy.
• Take corrective measures in respect of deficiencies noted regarding inspection reports of council or third-party audits conducted.
• In addition to the general responsibilities:
• Ensure that unauthorized people do not obtain access to pharmaceutical products in the wholesale or distributor pharmacy premises outside of normal trading hours.
• Establish policies and procedures for the employees of the wholesale and distributor pharmacy regarding the acts performed and services provided in the wholesale pharmacy
• Ensure the safe and effective storage and keeping of pharmaceutical products in the wholesale and distributor pharmacy under his/her direct personal supervision
• Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of pharmaceutical products.
• Ensure that the following registrations, recordings and licence are current and in place:
• The registration of the Pharmacist with the Pharmacy Council in accordance with the provisions of Section 14 of the Pharmacy Act.
• The premises licence of the wholesale or distributor pharmacy issued by the Director-General, Department of Health, in accordance with the provisions of Section 22(1) of the Pharmacy Act.
• The recording of the premises license of the wholesale or distributor pharmacy at the Pharmacy Council in accordance with Section 22(2) of the Pharmacy Act, read together with Regulation 8(5) of the “Regulations relating to Ownership and Licensing of Pharmacies”; and
• Assisting the RP to ensure that contracts (Service Level Agreements/ Technical Agreements) exist between service providers and principles stipulating where all responsibilities lie.
• To ensure that all employees are conversant with the system laid down for use and following the STANDARD OPERATING PROCEDURES.
• That the specified quality is maintained during storage and transport.
• To ensure that all logs are completed by the distribution / warehousing facility e.g. temperature control, cleaning, maintenance etc.
• To ensure that disposal or destruction of medicines is correctly and regularly performed under proper control so as not to be a health hazard.
• To ensure that an adequate pest control program is in place at the distribution facility, using acceptable food grade bait, and to ensure that precautions are taken to ensure that product contamination does not occur.
• To ensure that self-inspection audits are performed and any deviations followed up.
• To ensure that goods on arrival at the distribution facility are placed in quarantine, sampled for retesting after importation, and retained in quarantine until formally released where applicable.
• To update batch status to the market according to correct procedure.
• To check all relevant documentation to formally release final packed product for distribution where applicable.
• To ensure GDP/GWP training is provided to all employees on an annual basis.

Requirements

• Bachelor’s degree in pharmacy (BPharm).
• Active member with SAPC.
• Computer Literacy in MS Office
• 2-3 years’ experience as Pharmacist/Deputy Pharmacist.
• Experience in a Pharmaceutical distribution/wholesale environment would be an advantage.
• Experience in Quality Management Systems would be an advantage.
• Oracle R12 experience would be an advantage.

Closing Date 16 September 2026

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MAIN TASKS / RESPONSIBILITIES:

Production Operations

• Operate and monitor Rommelag BFS machines during production runs.
• Ensure production targets are achieved while maintaining product quality standards.
• Perform machine start-ups, shutdowns, product changeovers, and mould changes.
• Set up and control BFS process parameters relating to polymer extrusion, parison control, mould temperature, cooling, cutting, sealing, and container formation.
• Conduct line opening and line clearance activities in accordance with approved procedures.

Monitor critical process parameters, including:

• Temperature
• Pressure
• Fill volume
• Bottle weight
• Cycle times

Polymer melt condition and extrusion stability

• Sealing integrity

PLC alarms, interlocks, sensor feedback, and automated control status

• Ensure correct machine setup and operational readiness before production commencement.
• Report production outputs, process deviations, and equipment issues accurately and timeously.

Equipment Maintenance & Troubleshooting

• Perform first-line maintenance on BFS equipment and associated systems.
• Use machine HMI and PLC feedback to identify alarms, abnormal operating conditions, process deviations, and equipment interlock issues.
• Conduct routine machine inspections and preventive maintenance activities.
• Troubleshoot mechanical, electrical, pneumatic, hydraulic, and process-related faults.
• Diagnose BFS-related process issues linked to polymer flow, extrusion instability, mould alignment, trimming, sealing defects, container formation, and plastic material performance.
• Identify and escalate equipment abnormalities for further technical intervention when required.
• Assist Engineering and Maintenance teams during major maintenance and breakdown investigations.
• Ensure equipment remains in optimal operational condition to minimize downtime.

Quality Assurance

• Perform in-process quality inspections according to SOPs, GMP requirements, and batch documentation.

Monitor and inspect products for:

• Leaks
• Bottle weight compliance
• Fill volume accuracy
• Seal integrity
• Flashing defects
• Cosmetic defects
• Particulate contamination
• Print quality and traceability

• Complete all production and quality documentation accurately and legibly.
• Participate in deviation investigations, root cause analyses, and corrective action implementation.
• Support root cause analysis investigations by gathering process information, reviewing machine trends or events, identifying contributing factors, and documenting investigation outcomes.
• Prepare clear, factual, and GMP-compliant deviation, investigation, and technical reports where required.
• Assist with batch reconciliation and release-related activities.

Cleaning & Housekeeping

• Clean and sanitize BFS machines and production equipment according to approved procedures.
• Maintain housekeeping standards within manufacturing and cleanroom areas.
• Ensure adherence to contamination-control procedures and sterile gowning requirements.
• Participate in scheduled cleaning and sanitization programs.

Safety, GMP & Compliance

• Adhere to all Occupational Health and Safety regulations and company safety procedures.
• Always wear and maintain required PPE.
• Comply with GMP, SOPs, work instructions, and regulatory requirements.
• Participate in audits, inspections, training programs, and compliance initiatives.
• Apply pharmaceutical, GMP, and QMS training in daily operations, documentation practices, deviation handling, and compliance activities.
• Identify and report safety hazards, near misses, and unsafe conditions.

Continuous Improvement

• Contribute to process improvement initiatives aimed at increasing machine efficiency and reducing waste.
• Participate in root cause investigations and problem-solving activities.
• Use structured problem-solving tools to support root cause analysis, CAPA development, and documented effectiveness follow-up.
• Support implementation of corrective and preventive actions (CAPA).
• Assist in achieving departmental productivity, efficiency, and quality objectives.

Requirements

Qualifications

• Grade 12 / Matric.
• National Diploma, N6, Trade Certificate, or equivalent qualification in Mechanical Engineering and/or Electrical Engineering.
• Technical qualification with exposure to automated manufacturing equipment.
• Pharmaceutical manufacturing, GMP, and Quality Management System (QMS) training would be advantageous.
• BFS Technology qualification from the Plastics Institute or equivalent training would be advantageous.
• Dual qualification in Mechanical and Electrical disciplines (advantageous)
• PLC, automation, or instrumentation training (advantageous).
• Training in deviation management, root cause analysis, CAPA, and technical report writing would be advantageous.

  Experience 

• Minimum 3-5 years' experience in a pharmaceutical, sterile manufacturing, FMCG, packaging, or production environment.
• Experience operating, maintaining, or troubleshooting Rommelag Blow-Fill-Seal (BFS) filling equipment is highly advantageous.
• Practical experience with BFS process optimisation, including parison formation, mould operation, sealing performance, container integrity, and process parameter control.
• Experience working with pharmaceutical-grade polymers and plastics manufacturing principles, including extrusion, moulding, cooling, trimming, defect identification, and material-related troubleshooting.
• Experience performing first-line maintenance, fault finding, and equipment troubleshooting.
• Experience conducting line clearance, line opening, and changeover activities.
• Experience working within a GMP-regulated environment.
• Exposure to pharmaceutical training, QMS processes, deviation management, and CAPA systems would be advantageous.
• Experience participating in root cause analysis investigations and compiling clear investigation reports would be advantageous.
• Experience operating automated production equipment and process control systems.
• Experience operating, interpreting, and responding to PLC-controlled machine interfaces, alarms, interlocks, sensors, and automated process controls.
• Strong electronic, mechanical, and PLC fault-finding experience on automated filling or manufacturing equipment.
• Experience in cleanroom manufacturing environments would be advantageous.

Languages

• Proficient in written and spoken English.
• Additional South African languages would be advantageous.

Other

• Ability to read, understand, and complete technical documentation, SOPs, batch records, and quality documentation in English.
• Ability to work rotating shifts, weekends, public holidays, and overtime as required.
• Ability to wear sterile gowning and PPE for extended periods.
• Strong mechanical, PLC and electrical troubleshooting capability.
• High level of attention to detail and commitment to quality.
• Ability to work independently and within a cross-functional team.
• Must demonstrate a strong commitment to safety, GMP compliance, and continuous improvement.
• Computer literacy, including Microsoft Office and manufacturing-related electronic systems.
• Operation of Equipment with PLC
• Reliable transport to accommodate shift work requirements.

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Key Responsibilities: 

• Coordination support: Schedule training sessions, book venues or virtual rooms, arrange necessary equipment and related training events i.e. induction support and related logistics.
• LMS Administration: Competent in maintaining and capturing training data into the training managing systems i.e. Sage, Oracle.
• Record Keeping: Capture training attendance, course completions, and certifications accurately to maintain standards to statutory compliance.
• Reporting & Compliance: Generate analytics on training progress and a strict approach to data confidentiality.
• Stakeholder Support: Support Human capital administrators with training on the SAGE system and capturing as needed.
• Invoice & Financial Tracking: Reconcile, track, and log training-related invoices against purchase orders (POs), follow up on vendor payment processing with Finance.
• WSP/ATR & SETA/BBBEE Administrative Support: Support the Primary SDF with collation of data required for the Workplace Skills Plan (WSP) and Annual Training Report (ATR) submissions to secure grants and preparations for verifications.

Core Competencies:

• Technical Skills: Strong computer literacy, including Microsoft Office (Excel, PowerPoint) and familiarity with training system.
• Soft Skills: Exceptional organizational abilities, record keeping, meticulous attention to detail, time management, professional communication, people skills and ability to work independently.

Requirements

• Relevant Experience: 1 to 3 years of prior experience in a Learning and Development environment.
• Grade 12 / National Senior Certificate pass.
• Completed Bachelor’s degree; preferred Human Resources Management; Business administration or related.
• Certificate in Skills Development Facilitation (SDF) or ETDP-aligned related training and development-advantageous.

Advert closing date is 17 September 2026