QA Manager

Minimum Requirements:

• BSc or Degree/Diploma in Science subjects such as Pharmacy, Microbiology, Chemistry, Biotechnology
• At least 7 years in the QA field and 5 years Managerial experience
• To always act in a GMP compliant manner while carrying out all duties.
• Ensure that training needs and competence are kept up to date in the relevant GMP topics.

Core Competencies:

• Adapting and responding to change
• Coping with pressures and setbacks
• Achieving personal work goals and objectives
• Deciding and initiating action
• Leading and supervising
• Working with people
• Adhering to principles and values
• Presenting and communicating information
• Writing and reporting
• Applying expertise and technology
• Analysing
• Learning and researching
• Formulating strategies and concepts
• Planning and organizing
• Following instructions and procedures

Responsibilities of the Role:

• Ensure that Internal Audits are performed, recommendations made, and corrective and preventive actions (CAPA) identified as a result of such audits are effectively implemented.
• Ensure that Root Cause Analysis is performed according to S.O.P. to prevent recurrences of deviations, complaints, negative audit findings, reworks, reprocessing and failures /rejections
• Ensure that Product Quality Reviews (PQR) are being done for all products in accordance with S.O.P and the PQR schedule, and to review and authorize the reports and the recommendations/CAPA’s raised.
• Ensure quality and cGMP standards of compliance are maintained to avoid any level of Product Recall, and ensure compliance with Product Recall Procedures
• Ensure that there is an annual Quality Risk schedule and that risk assessments are conducted as per the schedule and Quality Risk Management SOP
• Ensure compliance to national / international regulatory requirements with respect to Quality Management Systems and current Good Manufacturing Practices (cGMP)
• Implement and maintain an effective Quality Management System within the plant.
• Ensure all Standard Operating Procedures are initiated, reviewed, approved and implemented as per the required process.
• Ensure that Master Batch Production Records (MBPR) and Master Batch Packaging Directions (MPDR) are compiled in accordance with the registered methods of manufacturing and packing.
• Ensure that all purchased items are received, inspected, sampled, labelled and handled according to S.O.P. and the principles of cGMP.
• Ensure that products are manufactured, packed and tested in compliance to registered methods of manufacturing, packing and testing.
• Ensure that there are systems for management and distribution of all GMP documents
• Ensure the archival and destruction of GMP records in accordance with relevant procedures
• Ensure that appropriate Validation procedures for processes, analytical methods, equipment, facilities and utilities are implemented and adhered to by approving all site validation documentation.
• Lead the Quality Review Meetings with Site and Executive Managers.
• Manage and front external cGMP audits of the site
• Manage and track all Audit Findings from External Regulatory Agencies and Third Parties (Contact Givers) ensuring that CAPA’s are initiated and closed within agreed target timelines
• Prepares and maintains CAPA response reports for all External audits
• Prepares Management Escalation forms for notification to the Applicant RP and GQA of failures in product stability, critical system failures and critical customer complaints
• Compiles detailed investigation reports on Product OOS, Critical Customer complaint and Adverse Events and Recalls as per SOP
• Compiles and maintains the Site Quality Manual and Site Master File ensuring current systems and processes are reported therein
• Ensures all site Regulatory Licenses and Certificates are up to date and required Retention Fees are submitted as per SAHPRA regulations
• Ensures Letters of Delegation are prepared and maintained for all Pharmacists
• Ensures the Site Legal File is maintained and kept up to date with the required records
• Ensures that Job Descriptions for Key Personnel on site are prepared by the relevant managers and copies retained in the Legal File
• Ensures that the site Organograms are prepared and maintained as per procedure
• Ensure that Product Codes (Item Masters) and Bills of Material on the Oracle system are set up in accordance with relevant procedures.
• Implement accurate measures of control and ensure adherence to requirements by acquiring knowledge of current legislation relevant to cGMP and the Quality Assurance function.
• Ensure training of Quality Assurance personnel is conducted in accordance with relevant procedure.
• Review key system SOPs for compliance gaps/ improvements and update/ implement changes
• Review cGMP systems, processes and practices on site against other international standards (WHO, FDA, EU, TGA, MHRA etc.) and implement required changes / updates accordingly
• Implement new SOPs on key business processes such as New Product Introductions etc.
• Review Quality and Technical Agreements with Contract Givers and Suppliers prepared by GQA, for correctness and accuracy of content relevant to the Clayville operations
• Ensure documentation required for new products identified as part of the VIP project, are prepared and submitted to Regulatory Affairs in accordance with relevant SOP
• Reviews and approves Analytical Method transfer protocols and reports prepared by R&D
• Ensures detailed Technical Transfers of new, reformulated products and changed/ improved manufacturing processes, are performed by RD&I into the Site
• Reviews and authorizes all Validation documentation, Risk assessments, Protocols, Final validation reports for all facility changes/upgrades, equipment, manufacturing processes
• Reviews Customer complaint trends and investigates options for implementing improvements/ CAPA’s of systems and processes to reduce recurring complaints