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Role Purpose:

Carry out specifically defined activities in terms of quality guarantees and/or quality assurance systems with the aim of contributing to the optimisation of quality within the organisation.

Required Role Qualifications:

• Grade 12 or NQF Level 4
• BSc Degree advantageous
• Minimum of 3 years’ QA/QC experience in pharmaceutical industry
• Good knowledge of cGMP, regulatory guidelines and ISO standards

Required Role Skills and Abilities:

• Computer literate with an excellent grasp of Microsoft Word and Excel
• Work independently while also being a team player.
• Effective written communication & excellent document management
• Excellent attention to detail
• Good time management skills

Required Role Responsibilities:

Quality assurance:

• Assist in the compilation, review and close out of quality incidents, e.g. OOS, non-conformances, deviations, change controls, CAPA’s, and
• Assist in the compilation and review of SOPs and work instructions.
• Perform GDP and GMP compliance checks during manufacturing.
• Coordinate and conduct internal audit and supplier audits.

Documentation:

• Issue document numbers.
• Issue, distribute and retrieve QMS documents.
• Compile and/or review documents.
• Maintain document version control including creating official copies; superseding and obsoleting QMS documents.
• Logging of quality incidents e.g. OOS, non-conformances, deviations, change controls, CAPA’s etc.
• Compile reports e.g. APQR & QMR.

Training:

• Prepare the training plan and training matrix.
• Coordinate the training programme
• Prepare and file training records.
• Prepare training presentations.
• Create general employee training awareness.

Trending:

• QMS data, e.g. OOS, non-conformances, deviations, change controls, CAPA’s, and deviations.
• Product data i.e. yields, OOS, deviations, CAPA’s, change control etc.

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