QC Analyst

3 weeks ago

Durban, South Africa SHARON NUROCK RECRUITMENT CC Full time
Minimum Job Requirements.
  • Matric with Maths and Science.
  • Bachelors 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 SOPs.
    • 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 SOPs for new equipment / methods.
    • Continuously review existing SOPs 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.

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