Functional Production, QC, Validation, Engineering, NPD, Warehouse, IT, Logistics, and Training Personnel.

Transcription

1 JOB DESCRIPTION JOB TITLE: QUALITY ASSURANCE OFFICER JOB TEAM: QUALITY ASSURANCE REPORTS TO: QUALITY ASSURANCE TEAM LEADER DATE UPDATED: MARCH 2011 Specification Purpose: Responsible for the review of batch manufacturing and packaging documentation, analytical data/systems, validation protocols and reports, coordination of complaint follow-up and various investigation teams, coordination of periodic product reviews. Responsible for performing assigned external and internal audits. Responsible for the provision of a recommendation for the disposition of the finished product following documentation review to the QA Manager, a QA Team Leader, a Senior QA Officer or the Technical/Quality Assurance Director. Functional Relationships: Production, QC, Validation, Engineering, NPD, Warehouse, IT, Logistics, and Training Personnel. Description: QA Officer March 2011 Page 1 of 5

2 1. Provide support to Senior QA personnel for release of the finished product. 2. Review & approve BMR and BPR documents and SAP Master Recipes against current GMP requirements and compliance with marketing authorisations. 3. Review and approve validation documentation as assigned. Review and support of SAP validation 4. Contribute to various cross-functional GMP problem solving groups within Douglas. Foster an environment of continuous improvement. 5. Perform internal audits of current Douglas systems, processes and procedures against the requirements of GMP Auditing of BMR and BPR documents. Relevant deviations & closed. Equipment, analytical and process validation activities complete. Send CoA and other documentation to clients as per the Client Requirements database. Master BMR and BPR documents and SAP Master Recipes are compliant with GMP and the marketing authorisation and available to Production on time. Executed BMR and BPR documents are GMP compliant. Ensure that validation protocols and reports are compliant with GMP requirements. Ensure that all processes are validated before products are released for commercial use. Approval of recommendations to transport successfully tested changes to SAP Production environment. 4.1 Work with Production. Laboratory and Engineering to identify deficiencies in systems, implement CAPAs and ensure that Perform audits as assigned on the Internal Audit schedule. Send agendas, write reports and assign CAPAs. Perform regular follow up to ensure that Train and support QA Officers during regular audits of Douglas departments. 100% review completed. All deviations & completed & closed within allocated timeframe. Audits are completed and materials released. Client documentation sent. Ensure all records are available to production at all times. Ensure all records are GMP compliant with marketing authorisation before any release is undertaken. Ensure all validation records are reviewed in a timely manner to support product launch dates. Ensure all records are GMP compliant. All deviations & completed & closed within allocated timeframe. Deficiencies are identified, documented and solutions sought and implemented in relevant Departments. Agendas, reports complete and CAPAs assigned. Procedures followed to ensure findings are closed All QA Officers are familiar with audit procedures and 30% 25% 5% Description: QA Officer March 2011 Page 2 of 5

3 6. Perform external audits of Douglas suppliers and contract service providers against the requirements of GMP. 7. Contribute to Quality Incident and OOS investigations to evaluate product quality and GMP aspects. 8. Contribute to the implementation of a Quality Management System into Douglas Manufacturing facilities. 9. Contribute to the Periodic Product Review procedure. 10. Contribute to the implementation of frequent GMP training and refresher training sessions Perform audits as assigned on the External Audit schedule. Send agendas, write reports and assign CAPAs. Perform regular follow up to ensure that Train and support QA Officers during regular audits of Douglas service providers. Ensure activities are in compliance with GMP, root cause analysis is conducted and the investigation is closed out. Perform regular follow up of CAPAs. Contribute to gap analysis. Include the application of quality risk management principles. Ensure compliance with QMS requirements with other Department heads. Implement and manage an effective Change Control system. Write and/or review and correct SOPs for full compliance with GMP, Regulatory and Pharmacopoeial requirements Ensure changes are approved as required and current formatting is used. Perform PPR for products as assigned on the PPR schedule by the QA PPR Co-ordinator. Follow PPR SOP, co-ordinate collection of all relevant data, identify trends, identify CAPAs as appropriate and ensure that all closed out. Provide feedback to all GMP related training courses. Identify non-compliance trends and provide training for Douglas personnel as appropriate. Agendas, reports complete and CAPAs assigned. Procedures followed to ensure findings are closed All QA Officers are familiar with audit procedures and All QI and 00S evaluated and actions are completed and closed within assigned timeframes. Contribute to the gap analysis for the GSK QMS as identified in individual objectives. Monitor QMS compliant procedures & implement changes / updates as required. Circulation of CRNs for approval. Follow up of actions to closeout. All SOPs reviewed within the 3 yearly review period or as required. PPR reports for assigned products completed. Procedures followed to ensure CAPAs are closed Provide feedback on GMP training material to Training dept. as appropriate. Compile training material to present to Douglas Description: QA Officer March 2011 Page 3 of 5

4 11. General Health and Safety Ensure that in all circumstances there is adherence to a Health and Safety working environment. Ensure that the Company is not put at risk in any circumstances due to inappropriate Health and Safety. personnel. No preventable accidents. Use all personal protective equipment provided. Nil lost time injuries. Satisfactory Health and Safety report from Health and Safety Coordinator. Compliance with Company policy and hazard identification procedures. Description: QA Officer March 2011 Page 4 of 5

5 3.0 Decision Making Scope 3.1 External Audits Representation of Douglas Pharmaceuticals to various external parties under supervision. 3.2 Policy / Procedure Adherence to company policies and procedures. 4.0 Essential Requirements 4.1 Education Tertiary Qualification in related field 4.2 Experience Minimum of 2 years experience in manufacturing environment Minimum of 2 years experience in GMP / GLP environment. GMP experience highly desirable Competence with Microsoft packages e.g. Word and Excel Pharmaceutical Industry experience desirable 4.3 Core Values Performance with Integrity Responsibility / accountability Commitment to continuous learning Respect for confidentiality Team Focused 4.3 Competencies Technical & professional skills Attention to detail Planning and organising skills Communication and interpersonal skills Commitment to team success Confident problem solving and decision making skills Results driven Innovative and creative APPROVED BY DEPARTMENTAL MANAGER: APPROVED BY HR: ACCEPTED BY EMPLOYEE: Description: QA Officer March 2011 Page 5 of 5