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Lab Analyst : QMS
Adcock IngramZA14 days ago
Job descriptionEnsure compliance to national / international regulatory requirements with respect to Quality Management Systems and current Good Manufacturing Practices (cGMP) within QC laboratory. Ensure awareness of cGMP and cGLP among all personnel. Ensure all Standard Operating Procedures (SOP’s) are updated Performing of departmental self-inspections (Monthly). Follow up with the lab section managers for closure of CAPA, CCP, OOS and Deviations, and identified Root Cause Analysis and Risk Assessment Ensure that all OOS, Deviations raised a, CAPA and CCP are properly documented, investigated and closed according to S.O.P. Assisting and ensuring that Annual Product Quality Reviews (APQR) documentation are completed and available for APQR reports. Follow up closure of all Internal or External Audit findings by ensuring recommendation are made, and corrective and preventative are identified as results of such audit and are effectively implemented. Escalate any critical and major CGMP and CGLP nonconformities found during departmental self-inspection to QC Laboratory Manager. Monthly submission of the departmental inspection to QA Submission of Internal / External audit finding feedback to QA Ensure all Authorized analytical reports are scanned by the LIMS administrators Tracking of deviation, CCP, CAPA, OOS, Root cause analysis and Risk assessment with status Authorizing of department self-inspection report Competence in planning, Moderate to High degree of work pressure Incumbent must be able to work with no supervision of work detail To act in a GMP and GLP compliant manner at all times while carrying out all duties. Ensure that training needs and competence are kept up to date in the relevant GMP and GLP topics. Study new guideline and policies from regulators to keep abreast with development and changes with regards to legal and regulatory requirements pertaining to pharmaceutical laboratory. Authorising of department self-inspection report Competence in planning, Moderate to High degree of work pressure Incumbent must be able to work with no supervision of work detail To act in a GMP and GLP compliant manner at all times while carrying out all duties. Ensure that training needs and competence are kept up to date in the relevant GMP and GLP topics. Study new guideline and policies from regulators to keep abreast with development and changes with regards to legal and regulatory requirements pertaining to pharmaceutical laboratory. Analytical Chemistry / Biotechnology Diploma / BSC in Chemistry 4 years of Laboratory experience preferable a pharmaceutical laboratory Have a good understanding of QMS. Broad knowledge of GMP regulations and Good Laboratory Practices Knowledge of commonly used analytical laboratory methods as well as knowledge of USP / BP Compendia methods Computer Literacy – MS Office (proficient in Excel, Word and Power Point). Able to work with people Good in Presenting and communicating information Good in writing and reporting Adapting and responding to change and able to Cope with pressures and setbacks. knowledge of auditing will be an advantage. Science jobs
Job title : Lab Analyst : QMS
Job Location : Western Cape,
Deadline : October 13, 2025
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