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
Key Responsibilities: § Project Planning, Execution, Monitoring: To assist in tracking and monitoring the product development & tech-transfer project plans through effective coordination & communication with internal & external stakeholders and ensure completion of projects action items within the pre-defined timelines, to meet business goals and objectives. § Projects Coordination, Documentation & Communication: To schedule projects meeting with internal-external stakeholders based on their availability. To attend projects meeting, communicate project discussions through Minutes of Meeting (MoM), maintain/update projects action item log or database, follow-up on pending action items with relevant stakeholders through email or discussions. § Reference Products Procurement and Logistics: To manage end-to-end RLDs procurement from various suppliers & handle logistics through negotiation skills & effective coordination to ensure timely availability of the samples to CMOs and CROs for different studies and maintain/update RLDs tracker. § Change Control Management: To initiate and manage end-to-end change control as a part of project initiation. § Additional Duties and Compliance: This job description outlines the core responsibilities of the role. The employee may be required to perform additional duties as assigned, in line with project and organisational requirements. The responsibilities and duties described may be subject to modification as necessary to accommodate changing organisational and project needs. Compliance with all company policies and standard operating procedures is mandatory, including adherence to regulatory and safety requirements pertinent to pharmaceutical projects. The employee is expected to maintain professional conduct and uphold ethical standards at all times. Education and Skills Required: § Up to five years of experience within the pharmaceutical sector Job Location: Vadodara office