Quality Assurance Pharmacist at MSD South Africa

Role Purpose

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

• Ensure all products are released for sale according to GMP requirements. Review of batch documentation prior to release.
• Ensure Quality standards/specifications and methods in line with Regulatory Specs and are maintained current. 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

• 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. 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.
• Responsible for QA review of artwork and artwork related updates on GLAMS requiring QA approval. Monitoring of Aire reports
• 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.
• Coordinate activities to be carried out for new products or changes to specs i.e. MIR, method transfer, reference standards etc.
• System Owner for Batch disposition
• Attend Community of Practice for Meetings and ensure implementation of new updates
• Participate in carrying out annual reviews for products
• Review and approve documents as necessary including master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports

• Participates in site audit activities and walkthrough audits, provide responses to audit findings and ensure completion of audit actions
• Post importation Exemption application for Fridge lines and specific product family. Participate in PITE project.
• 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 providing technical support with regards to deviation management and report writing.
• Participates in activities related to new product introductions.
• Seek opportunities for continuous improvement in Quality activities and projects and identify quality related trends
• Participate in 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 unbiased and honest judgements.
• Proficiency in use of Microsoft Word, Excel software
• Teamwork skills and flexibility
• Takes initiative
• Good oral and written communication essential

Experience Required

• At least five years’ experience in the pharmaceutical industry. An understanding and experience in quality assurance and analytical laboratory with a knowledge of HPLC and other main instrumental techniques is an advantage.
• Basic understanding of GMP particularly with reference to packaging operations.