Quality Assurance (Pharmaceuticals)

Job purpose (inclusive of, but not limited to)

To help assist and maintain the Quality Management System [QMS] in full compliance for the territory (UK);

To liaise with regulatory team, plant team, Quality Personnel and support to co-ordinate on batch releases;

Duties and responsibilities

• Complete co-ordination, documentation and assistance to Quality Personnel for maintaining the QMS (MIA, WDA & CD licences) and batch releases.
• Observing and complying with GMP and GDP.
• Author, review and approving the SOPs. Observing and complying with company and quality Standard Operating Procedures (SOPs).
• Preparing and reviewing of all Technical and Quality Agreements.
• Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events. Mainly co-ordination with sales and PV team.
• Helping/leading the regulatory audits, inspections, self - inspections as required.
• 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.
• Preparing Monthly stock statements, identifying discrepancies with stocks and investigating the same for resolution.
• Stock sheets for CD substances to be maintained in isolation.
• Preparing PQR [Product Quality review] documents with the help of PQRs received from the manufacturing plant and quality control laboratory.
• CAPAs and Deviation logs to be maintained.
• Yearly Mock-recalls to be performed.
• New customer & supplier addition and verifications with regards to WDA and GDMP to be done monthly.
• Liaising and coordinating for completion of AMT+MLTs (Analytical method transfer & verifications)
• Complete co-ordination for Batch release documents to be performed (from Plant and QC laboratory), inclusive of completion of investigation co-ordination for any OOS/OOT related to the batch. This also includes sourcing requisites for the batches from plant for testing.
• Co-ordination with the 3PL/4PL as required
• Variations for MIA and WDA wherever necessary to be filed with relevant regulatory authorities.
• Complete maintenance of QMS system online on secured platform provided by company
• 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.