Duties:Manage the QA Batch Release processEnsure that all documentation is completed on time and in full (OTIF) to support the timeous release of products.Coordinate the review of batch documentation for manufactured and or packed products on behalf for Technikon.Batch Release on behalf of companyCompiling and reviewing Quality documentation and SOPsWriting, reviewing and approving Standard Operating Procedures (SOPs).Management of customer and product queries and complaints Coordinate technical queries and product investigations. Responding to enquiries in a timely manner, giving advice on specials quality requirements in order to maintain the company''s reputation for customer service and technical acumen.Training Management System Keeping abreast with current GMP standards, requirements and industry best practices.Conducting GMP training or delivering internal training e.g. GMP and Hygiene Induction training when necessary.Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory.Observing and complying with company Health and Safety Policies.Observing and complying with company Standard Operating Procedures (SOPs).Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.Support, maintain and manage the QMS system with respect to following:Technical agreements, quality risk management, PQRs, self-inspection supplier audit reports, and SOPs.Conducting/assisting with internal self-inspection auditsParticipating in regulatory inspections.Observing and complying with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)Change management process - Implement and manage change via a change control system. Ensure that all changes are captured, assessed and trended appropriately.CAPA management system so that such CAPAs are raised, managed and trended periodically. Ensure that there is a system in place to assess CAPA effectiveness.Monitor and trend CAPAs associated with unacceptable risks to the organizationEnsure that a Training Management System is in placeImplement a training management system such that all GxP personnel within the organisation are adequately trained to perform their tasks.Coordinate the Implement and management of an effective Document Management System (DMS)Implement a DMS in line with GxP requirements and one that meets the operational requirements of the organisation. Ensure that the DMS allows for the swift creation and approval of master documents in an efficient and timeous manner.Quality Management ReviewsSupport quality management preparation reviews for internal discussion and senior managementOther Duties and ResponsibilitiesPerform other duties as and when requested, by the Line Manager, Executive Committee or colleagues within own area of skills and expertiseManagement ResponsibilitiesDirect Reports: 3Duties:Minimum Qualification and Experience requiredTertiary qualification; B PharmRegistration with the SAPC as a PharmacistKnowledge of QMS in the Pharmaceutical IndustryPrevious experience in quality or production.Competency Profile (Knowledge and Skills Required)Computer LiteracyMS WordMS ExcelMS PowerPointSysproTechnical CompetenciesKnowledge of Quality Management SystemsKnowledge of Training Management SystemKnowledge of Documentation Management SystemKnowledge of Audit ManagementKnowledge of Quality Risk ManagementKnowledge of CAPA ManagementKnowledge of the Regulatory Environment in SA; eequirements, regulations and guidelinesShould you not receive a response within 10 working days, please consider your application as unsuccessful
