Lab Analyst: QMS at Adcock Ingram

Key Job Outputs:

• Ensure 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.

Requirements

• 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.