QA COORDINATOR
Pharmaceutical Sector
Cape Town

Leading Pharmaceutical Company seeks a suitably qualified / experienced QA Coordinator to support, administer and maintain their systems, ensuring regulatory compliance and quality. The role will also entail mentoring and coaching of junior staff.

MINIMUM REQUIREMENTS:

• B.Sc degree in Chemistry or similar
• Minimum of 3 years work experience in a quality control or quality assurance position
• Detailed knowledge relating to all aspects of quality control, preferably within a pharmaceutical environment
• Sound knowledge of the most recent analytical laboratory techniques, packaging analysis, in-process requirements and production controls
• Knowledge of pharmaceutical, generics or consumer healthcare industries
• Knowledge of production and packaging technology
• High computer literacy and able to effectively use Excel
• Up to date knowledge of validation, GMP and GLP
• Highly accurate and has good attention to detail
• Highly organized and good planning skills
• Analytical and evaluative ability
• Pro-activity and task oriented
• Motivating staff and managing staff performance
• Functions independently at a high level, self disciplined
• Proactively anticipates problems and solves them constructively
• Effectively balances technical and commercial requirements
• Professional and presentable
• Effective written and verbal communication skills

KEY RESPONSIBILITIES:

• Good Manufacturing Practice (GMP, GLP, GWP)
o Maintain and coordinate all the GMP principles as required by the MCC as stipulated in the latest version of the MCC guidelines for cGMP and related systems and procedures to ensure compliance at all times.
o Maintain the individual GMP –programs and systems, which include the following, but are not limited to:
• stability program, PQR program, Deviations, CAPA’s, SOP’s & Audits

• Lot Releases
• Data Verification Management
• New Product Launches
o Coordinate the QA responsibilities for New Product Launches
• Reference Standard Management
• Documentation Management
• Supervisory responsibilities

*A detailed copy of the comprehensive duties / responsibilities for this role will be submitted to short-listed candidates who meet with the above requirements