Quality Specialist
3 weeks ago
KEY RESPONSIBILITIES:
§ Ensure timely collation, review, and assessment of pharmaceutical batch manufacturing, packaging, validation, and shipment documentation to support Qualified Person (QP) certification.
§ Liaise with external quality with regards to manufacturing site queries to ensure all required documentation is available to meet batch release timelines.
§ Liaise with warehouses to ensure all required documentation is available to meet batch release timelines.
§ Co-ordinate with EU site of Physical importation for QP import statement and EU sampling of QC testing, retention and reference sample.
§ Maintaining tracker for Retention and reference sample.
§ Co-Ordinate with EU testing Laboratory and outsource QP certification site for timely release of batches.
§ Raise/document, and review cGMP investigations, quality incidents, complaints, deviations, CAPAs, change control, and out-of-specifications/out-of-trends (OOS/OOTs); follows up to verify effectiveness.
§ Drive the execution of the PQS across the business to deliver the timely completion of quality records which are both effective and compliant with GMDP regulatory guidelines.
§ Support Quality manger in preparation of cGMP compliant quality management system (e.g. SOPs, forms etc.), day to day maintenance of system. Backup support to Quality manager in conducting Supplier and Customer initial Qualifications and periodic requalification.
§ Support cross functional teams with the timely completion of their PQS activities.
§ Complete assigned PQRs given by the Quality manager. Collects, collates, and compiles data for periodic product quality reviews from manufacturing site, including the preparation of PQR assessment reports for the Waymade product holding marketing authorization.
§ Maintains the Quality Department tracking spreadsheets for Documentation System, Quality and Technical Agreements, Approved suppliers list and customer list, overview of Deviations, Complaints & CAPA and PQRs to ensure that all required documents are in place and are updated when required upon change.
§ Provide backup support to the Quality Manager and perform delegated duties as required.
§ Support Quality Manager for QTA review process
§ Management of serialisation activities in Tracekey Portal for finished product batch awaiting QP certification.
Requirements:
§ Bachelor's / Master's degree preferably in Pharmacy.
§ Previous min. 7 years experience in a pharmaceutical GMP environment, preferably in a quality assurance, QMS, batch manufacturing documents review and shop floor QA.
§ Strong understanding of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulatory requirements.
§ Proficient in Microsoft Office applications (Excel, Word, Outlook); experience maintaining spreadsheets and quality tracking tools.
§ A proactive and collaborative approach to problem-solving and continuous improvement.
§ Strong communication skills, Attention to Detail, Problem-Solving Ability, Adaptability, Collaboration and Teamwork.
Job Location
: Vadodara , Gujarat Only
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