Quality Assurance Pharmacist

3 hours ago

Midrand, South Africa MSD Full time

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Position Overview - Basic Functions & Responsibility

Release products for sale according to GMP requirements. Review of batch documentation prior to release.
Maintain Quality standards/specifications and methods in line with Regulatory Specs i.e. for virtual stock.
Provide technical knowledge and remediate selected quality system gaps as a result of new or revised policies, procedures and guidelines and ensure that practices in the relevant systems are in alignment with our manufacturing division's SOP’s and our company's guidelines.
Ensures regulatory documentation is adequately checked against the in-use specifications.
QA review of artwork.
Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.

Primary Activities

**Product Release**:
Take into account all information available to make informed decisions for release to the market of any product including conformance to pre-determined specifications, deviation and OOS reports, production batch records, change control status, inspection of final packaged product. Release activities pertain to locally packed, imported, export product, packaging materials and bulk. Liaises with external and overseas laboratories to schedule testing, manage queries, co-ordinate lab transfers as required. Manage rejections and returned stock where necessary. Management of expired retention samples. Prepare documentation for product release e.g. Material inspection reports, COAs, transportation data, retained samples. Maintains DSV sampling list and communicates with DSV regarding changes.

**Packing component releases**:
Review and approve printed packaging components tested on the Text Verification system.
Release packing components on the SAP system
Site Process Stewart for Change Management. In this capacity, responsible for system overview and compliance, analysis of new requirements, training of new and existing users and remediation of gaps. Writes and / or reviews SOP’s and work instructions where required in alignment with GMP and our company's requirements. Maintains applicable metrics and general oversight of system. Participates in Community of Practice meetings and rolls out learnings to site. Updates or participates in reviews of other SOP’s as need arises.
Responsible for coordination and management of Change Review Board meetings for the site
Responsible for review of Orion notifications and initiation of the necessary site actions where required.
Responsible for QA review of artwork and artwork related updates on GLAMS requiring QA approval.
Ensures that the Quality Standards and specs and methods of testing in use in the external laboratories for final product testing are current by checking for new versions and reviewing regulatory and quality standard requirements and maintaining and updating MIRs to reflect the testing requirements.
Review and approve documents as necessary including master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports. This includes QA approvals on systems such as SAP COMET, APPIAN, QDocs, eLogs.
Participates in site audit activities and walkthrough audits, provide responses to audit findings and ensure completion of audit actions
Reviews applicable QA and test related filing documentation for Regulatory prior to submission to ensure information is accurate and whether changes will impact site activities.
Participates in activities of the Quality Council.
Responsible for classification of deviations.
Responsible for providing technical support with regards to deviation management and report writing.
Seek opportunities for continuous improvement in Quality activities and projects and identify quality related trends
Responsible for attending External Supplier meetings and Change controls

**Pharmacovigilance**: Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that they become aware of to the Designated Point of Contact (DPOC)

Qualifications/ skills

Minimum tertiary degree in Pharmacy
Knowledge of pharmaceutical Good Manufacturing Practices and regulatory requirements
Problem solving skills. Able to deal with situations requiring interpretative and evaluative thinking. Able to make unbi

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