Latest Vacancies at Aspen Pharma Group

Description

• Monitor and report on manufacturing compliance to GMP and statutory requirements.
• Monitor adherence to guidelines, procedures, and document controls.
• Related support and administrative tasks.

Requirements

Inspections and Verifications

• Perform visual inspections of rooms, machine parts and equipment.
• Verify that rooms and equipment are certified clean as per SOP.
• Verify scale and measuring equipment performance and daily.
• calibration as per SOPs, protocols, and schedules.
• Verify daily sampling, dispensing of materials and its mass/ volume.
• Perform housekeeping of rooms and equipment.

Line & Production processing

• Perform line sign on and closure
• Check and authorize packaging line clearance
• Order and maintain substance materials
• Perform batch reconciliations to product specifications and quality
• Monitor production process in line with standards and specifications

Process and system improvements

• Manage change control programs and deviations/ concessions in line with SOPs, standards and product quality and specifications
• Manage and resolve customer complaints
• Optimize processes and identify gaps in policies/ procedures

Compliance & Auditing

• Conduct shift GMP checks and ensure continued compliance
• Conduct environmental checks and check expiry dates of agents
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Check preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required

Training and technical expertise

• Train new PMAs on SOPs
• Identify refresher or awareness training needs

Administration & Record keeping

• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required

Skills Required

Background/experience

• Post Basic registration as Pharmacist Assistant with Pharmacy Council
• 1- 3 years’ Pharmacist Assistant experience
• Pharmaceutical manufacturing experience advantageous

Specific job skills

• Basic technical knowledge of pharmaceutical manufacturing, standards, and compliance requirements
• Ability to interpret and implement policies, processes, and objectives

Competencies

• Interrogating information
• Meeting deadline
• Finalizing outputs
• Maintaining accuracy

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Description

Fine Chemicals requires the services of a Technical Cleaner for the Site and Facility Department. To qualify for these positions the most suitable candidates must fulfill the following requirements:

Requirements

JOB REQUIREMENTS:           

• Matric / Grade 12
• Experience in cleaning and housekeeping in an industrial environment
• Qualified forklift driver or able to be trained as one
• Knowledge and understanding of chemical products and correct usage
• Must have high safety, health, and hygiene standards
• Must have the ability to be trained and in good health
• Must be able with solvent drum handling, working at heights, and working in confined spaces

BASIC JOB FUNCTIONS (Brief Summary):

• All roadways and areas external to buildings, though generally not including grassed or garden areas.
• Remove and sort all solid waste to the solid waste handling area.
• Ensure that production hazardous/non-hazardous waste bins are emptied and returned regularly during the day.
• Ensure redundant reagent glass bottles from Laboratories are removed when the bin is full.
• All refuse to be taken for sorting and compaction or other.

• Assisting with office removals, transfers of files, etc.
• Collection and handling of all waste generated by Production, Laboratories, Warehouses, and Offices.
• Monitoring and cleaning of all tank and drum bunds
• Drumming and movement of waste and treated products from the Solvent Recovery System and Hazardous Aqueous Waste (HAW) treatment plant
• Charging of drummed HAW to HAW tank farm.
• Cleaning of utilities and technical equipment within production areas (ventilation ducting, utilities pipe work, scrubber ducting, and hard-to-reach process pipework)
• Cleaning of production void areas
• Cleaning of production Plant Rooms
• Assist in deep cleaning of production areas and equipment when required (e.g. annual SS vessel internal polishing, deep cleaning of SS flooring, etc.)
• Assist with site material movement where required
• Assist with general audit preparation work where required
• Assist with fire watch duties where required
• Dispensing of Raw Materials in Raw Material Stores

PERSONAL ATTRIBUTES (Brief Summary):

• Must be honest and reliable.
• Able to work in a team as well as independently when required.
• High attention to detail and accuracy.
• Good communication skills.
• Ability to work under pressure.
• Able to work extended hours at short notice if required.
• Must have good etiquette and interpersonal skills 

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Job purpose

• Perform validation exercises of production and lab equipment, utilities, packaging, and processes to ensure specific standard of compliance is met.

Responsibilities

Planning and Operational Support

• Act as a technical/ subject matter resource
• Facilitate implementation of current processes
• Identify gaps in current policies and procedures.

Validation

• Perform validation exercises in compliance with GMP standards and validation schedules.
• Maintain compliant status of equipment and processes.

Qualification

• Perform the relevant operational qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as per intended use.
• Perform the relevant performance qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as intended over time and within limits.
• Investigate and report OOE results and perform re-tests.
• Participate in change control assessments to ensure compliant status of affected equipment is not compromised.
• Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered to
• Ensure documents and procedures to operate and maintain equipment are in place.

Requalification

• Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol.
• Prepare and perform re-qualification of equipment and utilities as per SOP.

Reporting and record keeping

• Compile, maintain and update validation documentation as per SOP and QMS
• Generate validation reports on a weekly/ monthly basis.

Requirements

Background/experience

• National Certification (N4-N6) or Trade Tested Artisan with 2-4 years’ related experience
• degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
• Aseptic pharmaceutical manufacturing process and automated packing experience

Specific job skills

• Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products.
• Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives. 

Competencies

• Interrogating information
• Maintaining accuracy
• Following procedures
• Technical writing

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Job purpose

• Manage and coordinate validation testing to support tech transfers.
• Manage and coordinate laboratory specifications & testing methods.
• Provide analytical, maintenance and QC lab support.
• Ensure continuous compliance of lab with GMP standards.
• Ensure that products are produced, tested, and stored according to the required SOP’s and documentation.
• Performance management of direct reports

Responsibilities

Planning and Section Management

• Provide input into operational planning of section, and prioritization of objectives.
• Provide input into, interpret and execute policies and procedures.
• Provide input into and manage budgets and resource requirements for section.
• Provide section staff with day-to-day direction and tasks.

Validation testing to support technology transfers.

• Manage and monitor compliance of QC lab testing activities to GMP, quality standards, and product specifications.
• Manage and coordinate lab preparation activities according to SOPs (samples, working area(s), PPE and lab equipment)
• Prepare and implement maintenance and calibration schedules and records.
• Ensure set priorities and targets are achieved, identifying constraints and solutions.
• Investigate and report Out of Specifications (OOS)
• Enforce Good Lab Practice

Specification upgrade and maintenance

• Manage and coordinate specification preparation, upgrade and maintenance projects according to SOPS and project plans.

Lab Quality Reviews & Training

• Validate batch documentation approvals.
• Review and approve corrections in batch documentation.
• Identify and coordinate training of staff on SOPs.

Deviations Investigations

• Manage and coordinate deviation investigations and reporting.
• Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies.
• Manage implementation of operational changes to SOPs and processes.

Governance, Risk & Compliance

• Provide input to QC for improvement of risk-based compliance systems.
• Monitor implementation and correct own and/or team compliance with legislation, policies and procedures;

Requirements

Skills Required

Background/experience

• Bachelor's Degree in Chemistry or Microbiology with 5 years’ related experience
• Laboratory and Good Laboratory Practice experience
• Supervisory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods and analytical method verification / transfer testing
• Knowledge of value chain and MCC principles
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives.

Competencies

• Interrogate Information
• Managing Performance
• Planning and Organizing
• Customer Awareness

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OBJECTIVE OF ROLE

• To continuously provide high quality digital support and training to the Aspen SA Commercial User community.

KEY RESPONSIBILITIES

• Troubleshoot and support employees with hardware and software issues in person, remotely and via phone (computer / mobile device issues
• Timeous escalation of hardware and software issues through the right channels
• Provide guidance and support for office-based and remote users, including advising on and troubleshooting home office connectivity issues
• Work closely with the Project Management Office (PMO) and play an active role in the transition of IT-managed projects to the “live” environment
• Support new products deployed by the Application and SecOps teams
• Update the relevant service management systems
• Is responsible for their own upskilling through continuous learning, to ensure their knowledge of new platforms and systems always current
• Ensure that knowledge of new platforms and systems is proactively shared with end users
• Support virtual meetings (internal and external meetings) Provide guidance and support on Audio Visual systems and equipment
• Provide training and guidance to external presenters who may be unfamiliar with Aspen’s tools
• Assist in the creation and maintenance of online forms (Microsoft Forms) and SharePoint sites.
• Continuous improvement of digital support services (from the logging process through to resolution)
• Knowledge sharing back to the relevant IT teams of issues found that can be avoided / eliminated / managed centrally

Requirements

EDUCATIONAL REQUIREMENTS

• Matric / Grade 12 Certificate
• Diploma or Certificate in the Information Technology field would be an advantage, with the ITIL qualification being ideal (or experience as listed below) 

EXPERIENCE REQUIRED

• Minimum of three (3) years' experience in an Information Technology environment
• IT Service / Help Desk experience is advantageous
• Experience in Microsoft O365 Cloud is an advantage

SOFT SKILLS

• Working knowledge of common information technologies and systems
• Communicating complex concepts to a general audience
• Troubleshooting common IT issues, utilizing a problem-solving mindset
• Excellent time management skills
• Ability to think Analytically
• Customer-centric orientation
• Excellent interpersonal & communication skills (verbal & written)
• Passion for upskilling, training and empowering others
• Outstanding ability to be a Team player