SUMMARY:
This large pharmaceutical manufacturing company is currently looking for a suitably qualified and experienced Quality Control Analyst to ensure quality, safety and efficacy of products through quality control processes applying the principles of good laboratory practice and good manufacturing practice.
N.B. You must be able to work night shift.
POSITION INFO:
Minimum Job Requirements.
- Matric with Maths and Science.
- Bachelor’s Degree or National Diploma in Biochemistry, Chemistry, Biotechnology, Pharmaceutical Science or related Science field.
- Minimum 2 years analytical. Laboratory experience.
- Good knowledge of the full Microsoft Office Suite.
Key Performance Areas:Report to the Lead: QC Analyst:
- Perform testing of starting, intermediate and final products and other samples:
- Plan, organise and co-ordinate verification and test incoming samples in accordance with the product specifications, production requirements and/or dossier requirements.
- Prepare reagents/buffers according to correct recipes/procedures.
- Perform process sampling or process verification where required to fulfil testing requirements.
- Perform analytical tests according to the approved SOP’s.
- Ensure accuracy and validity of the results by checking controls and using approved statistical methods.
- Record test results in the relevant protocol and report within set timelines.
- Process results and monitor trends periodically as per schedule.
- Track and monitor the progress of testing and reporting of samples.
- Participate in international collaborative studies with national and internationally recognised bodies.
- Prepare in-house controls and standards.
- Provide technical expertise to internal customers.
- Perform out-of-spec investigations and handle product quality related complaints.
- Laboratory maintenance
- Laboratory testing.
- Perform routine maintenance of lab equipment.
- Perform routine general laboratory maintenance.
- Monitor the lab as per schedule.
- Monitor departmental stock usage and wastage of test kits and reagents and laboratory consumables.
- Method development and validation and equipment qualification:
- Perform test and method validations according to internal QC program and perform validations on new equipment.
- Draw up user requirement specifications.
- Prepare validation/qualification protocols; and equipment qualifications.
- Prepare validation report/s.
- Implement method/equipment.
- Develop/optimise methods for approval by QC Manager.
- Monitor performance of assigned method/s and instruments.
- Raw Material Testing
- Perform sampling, testing and reporting of raw materials such as chemicals, media, water, printed and packaging components by:
- Following the appropriate procedures/practise;
- Receiving and retaining samples in the appropriate containers and correct locations/conditions.
- Quality Management
- Uphold quality standards. Ensure GMP/GLP is followed at all times.
- Ensure all tasks and functions are performed in compliance with cGMP.
- Constantly ensure the quality of products by conducting stability studies.
- Ensure operational compliance by management of non-compliance through review of root cause analysis and implement required corrective action within agreed timeframes.
- Analyse systems non-conformances and elevate problems and/or solutions.
- Monitor compliance to safety policies and procedures.
- Compile SOP’s for new equipment / methods.
- Continuously review existing SOP’s within the required timeframe.
- Monitor maintenance and calibration programmes for the laboratory.
- Participate in internal audit programme to ensure effective functioning of the quality systems.
- Provide training and assessment of new staff.
- Attend meetings and training sessions as required.
- Administrative tasks:
- Perform any required administrative tasks.
- File results for easy retrieval.
- Archive documents regularly.
- Ensure appropriate maintenance of records.
- Communication and Co-ordination:
- Liaise with suppliers and Instrument Engineers.
- Compile and submit reports timeously.
- Provide effective feedback on investigations and progress.
Core Competencies:- Personal leadership.
- Business impact.
- Leading and influencing others.
- Customer focus.
- Leadership skills.
- Problem-solving skills.
- Analytical thinker.
- Technical/professional knowledge.
- Attention to detail.
- Good communication skills.
- Interpersonal skills.
NB! This job is now closed. You can apply for other jobs by uploading your CV.
