Description:
Minimum Requirements:Science or Chemistry or relevant Degree Comprehensive understanding of cGxP regulations and relevant regulatory guidelines. 5-10 years of experience in a technical quality control role within the pharmaceutical sector. At least 5 years of experience in laboratory supervision At least 2 years of experience in the release of analytical results Demonstrated experience in document preparation and control. Proven ability to implement, manage, and optimize Laboratory Information Management Systems (LIMS). Experience implementing and managing an Electronic Quality Management System (EQMS). Duties and Responsibilities:
QUALITY ASSURANCE:
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 RELEASE DUTIES:
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 a
06 Mar 2025;
from:
gumtree.co.za