Jobs Available at Adcock Ingram

Requirements

• Bachelor of Commerce Qualification or Any other relevant Finance Qualification 
• NSFAS funding recipient
• Age between 18 and 35
• Must be unemployed with no or limited work experience
• Comply with definition of “Black People” as defined in the Broad-Based Black Economic Empowerment Act 53 of 2003 as amended by Act 46 of 2013

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Minimum Requirements 

• Grade 12 or equivalent
• 2 to 3 years' experience in production/QA experience

Key Job Outputs

• Ensure that line clearance/line opening has been performed as per SOP.
• Check that the material used is released and per bill of material
• Check that the scales that are in use are within calibration and that machine parameters are per SOP.
• Ensure that the plant manufacturing log book has been completed
• Pull Chemistry, Bioburden and Pyrogen samples.
• Sample submission is on time to the lab.
• Raises, hold notices for non- conforming products
• Ensure that the corrected printed material have been delivered to product
• Perform printed material reconciliation
• Assist in compliance with GMP and GDP
• Assist in investigation process for Audits and deviations
• Relieve operators when required

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Key Job Outputs:

Routine testing as per relevant Test Methods and procedures for Raw Materials, In Process samples, Finished Products, Process Validations, Stability, Post Importation:

• Carry out analysis following the method of analysis and ensuring that technical data generated meets specification and obtain release within the agreed timelines.
• Evaluate data to ensure compliance to release specification.
• Generation of analytical test data reports.
• Conducting investigations required for out of specification results together with supervisor.

Process validation and customer complaints testing (If required):

• Carry out analysis required as per validation protocol.
• Evaluate data to ensure compliance to specification.
• Recording results as per protocol.
• Ensure timeous product complaint analysis as per procedure

Documentation Compiling and Review

• Ensure that all documented activities are in compliance with guidelines and procedures
• Total Quality Management (GMP and GLP): Ensure that scientific integrity of data is maintained
• Review own work to ensure accuracy, completeness and compliance with departmental procedures.
• Ensure that all documented activities are in compliance with guidelines and procedures.
• Report deviations and out of specification results immediately.

Requirements

• National Diploma/BSc Degree in Chemistry and/or equivalent
• 2 Years Pharmaceutical Laboratory Testing experience (Essential)
• Ability to multi-task
• Ability to think analytically
• Critically Attention to detail
• Good communication skills (spoken and written) 
• Strong background in Chemistry and Physics.
• Able to follow instructions and production schedules

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Key Job Outputs:

• Ensuring compliance with national / international regulatory requirements with respect to Quality Management Systems and current Good Manufacturing Practices (cGMP) within QC laboratory.
• Ensuring awareness of cGMP and cGLP among all personnel.
• Ensuring that all Standard Operating Procedures (SOP’s) are initiated, reviewed, approved and implemented as per the required process. (When assistance is required by Support Manager).
• Planning and allocation of stability work.
• Ensuring that all Stability Products are tested in compliance to registered analytical methods and able to review the documents when required.
• Assisting the Stability and Process validation Manager to ensure that there is a system for management and distribution of all GMP/GLP documents.
• To be able to communicate all the products Out of specification and relevant updates to the Stability Program Manager.
• Ensuring that all customer complaints and all the other testing required for analysis in the department are tested in accordance with the relevant SOP.
• Ensuring that all Deviations and Change controls and CAPAs raised are properly documented, investigated and closed according to SOP.
• Assisting and ensuring that Product Quality Reviews (PQR) documentation is being done for all products in accordance with SOP and the PQR schedule, review and sign the reports.
• Ensuring participation and compliance with Out of Specification and Anomaly investigations and procedures.
• Ensuring that all the other products received in the laboratory such as Intermediates, finished products and Raw materials are approved and Authorized when required.
• Ensuring that Stability products and all the other products such as Finished products, Process validation and Raw materials received in the laboratory meet QC Standards, and cGMP SAHPRA requirements.
• Reviewing and confirming the compliance of test results ensuring adherence to product release specifications.
• Assisting with ensuring that all specifications, test methods and other quality control procedures are available.
• Ensuring training of QC Laboratory personnel is conducted in accordance with relevant procedure for relevant teams.
• Ensure all analysts are trained and competed to perform their duties and able to conduct training when necessary.

Requirements

• BSc degree/Diploma in Analytical Chemistry.
• Minimum 5 years’ experience in the QC laboratory, preferably pharmaceutical industry
• Understanding of Quality Control, and Good Laboratory Practice guidelines and firm understanding of GLP requirement for generated data integrity
• Good understanding of QMS.
• Computer literacy, word, excel.
• Review of analytical data will be an advantage
• HPLC, UPLC, GC and AA experience required (minimum of the at least 3 of the 4 skills)
• Decisiveness and action orientation and strategic Thinking ability
• Supervisory skills and able to do problem Solving

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Key Job Outputs:

• Ensure compliance to national / international regulatory requirements with respect to Quality Management Systems and current Good Manufacturing Practices (cGMP) within QC laboratory.
• Ensure awareness of cGMP and cGLP among all personnel.
• Ensure all Standard Operating Procedures (SOP’s) are updated
• Performing of departmental self-inspections (Monthly).
• Follow up with the lab section managers for closure of CAPA, CCP, OOS and Deviations, and identified Root Cause Analysis and Risk Assessment
• Ensure that all OOS, Deviations raised a, CAPA and CCP are properly documented, investigated and closed according to S.O.P.
• Assisting and ensuring that Annual Product Quality Reviews (APQR) documentation are completed and available for APQR reports.
• Follow up closure of all Internal or External Audit findings by ensuring recommendation are made, and corrective and preventative are identified as results of such audit and are effectively implemented.
• Escalate any critical and major CGMP and CGLP nonconformities found during departmental self-inspection to QC Laboratory Manager. 
• Monthly submission of the departmental inspection to QA
• Submission of Internal/External audit finding feedback to QA
• Ensure all Authorized analytical reports are scanned by the LIMS administrators
• Tracking of deviation, CCP, CAPA, OOS, Root cause analysis and Risk assessment with status
• Authorizing of department self-inspection report
• Competence in planning,
• Moderate to High degree of work pressure
• Incumbent must be able to work with no supervision of work detail
• To act in a GMP and GLP compliant manner at all times while carrying out all duties.
• Ensure that training needs and competence are kept up to date in the relevant GMP and GLP topics.
• Study new guideline and policies from regulators to keep abreast with development and changes with regards to legal and regulatory requirements pertaining to pharmaceutical laboratory.
• Authorising of department self-inspection report
• Competence in planning,
• Moderate to High degree of work pressure
• Incumbent must be able to work with no supervision of work detail
• To act in a GMP and GLP compliant manner at all times while carrying out all duties.
• Ensure that training needs and competence are kept up to date in the relevant GMP and GLP topics.
• Study new guideline and policies from regulators to keep abreast with development and changes with regards to legal and regulatory requirements pertaining to pharmaceutical laboratory.

Requirements

• Analytical Chemistry / Biotechnology Diploma /BSC in Chemistry
• 4 years of Laboratory experience preferable a pharmaceutical laboratory
• Have a good understanding of QMS.
• Broad knowledge of GMP regulations and Good Laboratory Practices
• Knowledge of commonly used analytical laboratory methods as well as knowledge of USP / BP Compendia methods 
• Computer Literacy – MS Office (proficient in Excel, Word and Power Point).
• Able to work with people
• Good in Presenting and communicating information
• Good in writing and reporting
• Adapting and responding to change and able to Cope with pressures and setbacks.
• knowledge of auditing will be an advantage.

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Key Job Output:

• Evaluate and provide advice with respect to current formulations and processes.
• Provide improvements for product processes to increase manufacturing efficiencies.
• Compile protocols and reports for relevant activities.
• Observe product manufacturing processes in the facility and record data as per approved protocols.
• Collate, analyse and discuss data in respective reports, and make recommendations.
• Conduct risk assessments on products and processes.
• Control and submission of samples for analysis and providing required documentation.
• Assist with investigations and report writing.
• Collate data from multiple sources for investigations.
• Complete investigations with workable solutions.
• Identify, where possible, root causes of issues and plan a course of action for further investigation and/or corrective actions.
• Complete investigations within allocated timelines.
• Evaluate new product manufacturing documentation.
• Ensure new products are optimised and introduced successfully into the manufacturing facility.
• Conduct trials as per SOP where necessary using relevant documentation.
• Compile, update and review SOP’s timeously according to current procedures.
• Raise relevant deviations, change controls, CAPAs and incident forms where necessary.
• Assist with preventative/corrective actions with regards to audit responses.
• Ensure all work performed is of the highest quality and in full compliance with GxP’s, SOP’s, regulations and safety standards.
• Administrative duties (filing and maintaining relevant data bases).

Requirements

• Matric Certificate.
• Appropriate tertiary qualification and relevant experience.
• Pharmacist Assistant Basic / Post-Basic advantageous but not necessary.
• Excellent computer literacy especially in MS Office mandatory.
• 3 - 5 years’ experience in a pharmaceutical manufacturing environment. (specifically in production) or Direct experience is process validation.
• Understanding of GLP, GMP, Regulatory guidelines (SAHPRA, ICH, etc.).