Quality Assurance Lead

SUMMARY:
Position available for a Quality Assurance Lead and Release person. You will ensure lab operations meet SAHPRA standards and client needs by managing the Quality Management System, authorizing analytical result releases, and overseeing laboratory compliance and coordination with the Technical Director. This role is crucial for maintaining high compliance standards, reviewing analytical data, and ensuring the laboratory functions efficiently and effectively.

POSITION INFO:
Minimum Requirements:

1. Science or Chemistry or relevant Degree
2. Comprehensive understanding of cGxP regulations and relevant regulatory guidelines.
3. 5-10 years of experience in a technical quality control role within the pharmaceutical sector.
4. At least 5 years of experience in laboratory supervision
5. At least 2 years of experience in the release of analytical results
6. Demonstrated experience in document preparation and control.
7. Proven ability to implement, manage, and optimize Laboratory Information Management Systems (LIMS).
8. Experience implementing and managing an Electronic Quality Management System (EQMS).

• Guarantee the Quality Management System is evaluated, revised, put into practice, and sustained.
• Conduct regular evaluations of records.
• Direct the creation and upkeep of Standard Operating Procedures following applicable standards.
• Administer the central record system, encompassing but not limited to: the Quality Manual, Site Master File, Validation Master Plan, analytical procedures, etc.
• Monitor the trustworthiness of data generated by equipment and laboratory workflows.
• Propose remedial and proactive measures, and oversee the completion of these actions.
• Oversee the archiving of all laboratory records, such as procedures, obsolete documents, and reports.
• Control the training record system.
• Organize and conduct internal audits in partnership with the Laboratory Management.
• Coordinate supplier relationships with QA and administrative colleagues.
• Prepare for and handle external client inspections.
• Take responsibility for compiling and finalizing inspection reports.
• Communicate with clients regarding quality assurance issues.
• Observe laboratory activities and procedures to ensure adherence to current guidelines.
• Validate and authorize analytical outcomes.
• Approve service providers, subcontractors, and vendors according to established procedures.
• Oversee waste disposal in accordance with SOPs, working with the Laboratory team.
• Oversee the implementation and maintenance of the equipment maintenance program, reporting equipment issues, and arranging repairs in collaboration with the Laboratory Administrator.
• Execute routine equipment calibration and the calibration schedule in partnership with the Laboratory Administrator.
• Monitor and control sensitive data and documentation

• Supervising outsourced projects and ensuring the accuracy of results from external laboratories, working closely with the Laboratory Management and Laboratory Administrator.
• Preparing and consolidating reports, validating results, confirming calculations and source data, and authorizing analytical and final reports.
• Monitoring and reporting on adherence to regulatory standards for analytical services, encompassing compliance tracking, trend analysis, out-of-specification reporting, and deviation management.
• Reviewing and processing vendor documentation in conjunction with the Laboratory Administrator.
• Maintaining client relationships and promoting the organization's services, while representing the company professionally.
• Ensuring the analytical laboratory operates under Good Manufacturing Practices (GMP), by adhering to and enforcing all applicable SAHPRA regulations and requirements.
• Managing key control and laboratory access.
• Controlling Schedule 5 and 6 controlled substances.
• Safeguarding and regulating sensitive information and records.
• Contributing to the development and creation of Quality Management instruments.