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
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
1. Audit Management Plan, schedule, and coordinate supplier audits (API, CMO, intermediates, and service providers) in line with global quality standards. Maintain supplier audit data, audit schedules, and audit tracking systems. Manage pre-audit preparation, audit conduct, and post-audit follow-up activities. Review and monitor CAPA (Corrective and Preventive Action) plans to ensure timely and effective closure. Support internal and external audit readiness. 2. Supplier Oversight and Communication Maintain consistent communication with Contract Manufacturing Organizations (CMOs), API suppliers, and other partners to ensure compliance with agreed quality standards. Evaluate supplier performance and support supplier qualification and requalification processes. Manage supplier documentation and ensure data integrity within the supplier management database. 3. Compliance and Quality Systems Ensure adherence to GMP, GDP, and other relevant regulatory and corporate compliance requirements. Identify and mitigate risks related to supplier quality and audit management. Support deviation investigations, change controls, and quality risk assessments where applicable. 4. QTA (Quality Technical Agreement) and System Responsibilities Lead and coordinate Quality Technical Agreement (QTA) drafting, review, and maintenance in alignment with corporate templates and regulatory expectations. Manage the supplier module in TrakWise, ensuring data accuracy and timely updates. Collaborate cross-functionally with global QA, procurement, and technical teams for seamless quality governance. Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or a related field. Experience: 10-15 years of experience in quality assurance, compliance, or supplier audit management within the pharmaceutical or biopharmaceutical industry. Strong understanding of GMP/GDP guidelines, quality systems, and regulatory expectations. Experience with supplier audits, CAPA management, and QTA handling preferred. Hands-on experience with electronic quality management systems (e.g., TrakWise, Veeva, or similar) is an advantage.
Responsibilities - Implementing and maintaining the quality management system - Manages, performs and reviews cGMDP investigations, quality incidents, deviations, CAPAs, change control, Risk assessment, complaints, Recall and out-of-specifications/out-of-trends (OOS/OOTs); follows up to verify effectiveness. - Support the coordination and preparation of Quality Risk Management - Development and implementation of cGMDP compliant systems, including internal SOPs, forms, templates and work instructions. - Supports the preparation and participation in the Quality Management Review - Maintain a system for distribution/logistics and product quality complaint handling ensuring timely completion and reporting including co-ordination with third party investigation. - Prepare PQR planner, ensure PQR assessment completed as per planner and prepare PQR assessment report as required. - Management for product Launch process - Management for product stability - Responsible for the preparation and maintenance for audit programme - Participate for the preparation of health authority inspection and customer audit - Develop and deliver training programs to enhance quality awareness and ensure that employees understand and follow quality procedures. Track and maintain employees traning record. - Manage third party notification process – Review and approval of CMO change control, deviation - Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and that necessary corrective measures are put in place. - Prepare and execute annual quality plan as per schedule - Review of batch documentation for QP batch certification - Backup support for Quality specialist Required skills/ competences The Quality Manager needs to have the proper skills, experience, and knowledge in GMP, GDP activities and an educational requirement of a master’s degree, preferably in Pharmacy: - 10-12 years of progressive experience within the GMP and GDP quality function of the pharmaceutical healthcare industry. Experience of working with the BV market will provide a competitive advantage. - Strong communication skills and excellent in English (writing & speaking). - Integrity, able to maintain a balance between commercial decisions and maintaining compliance with quality.
Responsibilities - Implementing and maintaining the quality management system - Manages, performs and reviews cGMDP investigations, quality incidents, deviations, CAPAs, change control, Risk assessment, complaints, Recall and out-of-specifications/out-of-trends (OOS/OOTs); follows up to verify effectiveness. - Support the coordination and preparation of Quality Risk Management - Development and implementation of cGMDP compliant systems, including internal SOPs, forms, templates and work instructions. - Supports the preparation and participation in the Quality Management Review - Maintain a system for distribution/logistics and product quality complaint handling ensuring timely completion and reporting including co-ordination with third party investigation. - Prepare PQR planner, ensure PQR assessment completed as per planner and prepare PQR assessment report as required. - Management for product Launch process - Management for product stability - Responsible for the preparation and maintenance for audit programme - Participate for the preparation of health authority inspection and customer audit - Develop and deliver training programs to enhance quality awareness and ensure that employees understand and follow quality procedures. Track and maintain employees traning record. - Manage third party notification process Review and approval of CMO change control, deviation - Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and that necessary corrective measures are put in place. - Prepare and execute annual quality plan as per schedule - Review of batch documentation for QP batch certification - Backup support for Quality specialist Required skills/ competences The Quality Manager needs to have the proper skills, experience, and knowledge in GMP, GDP activities and an educational requirement of a master's degree, preferably in Pharmacy: - 10-12 years of progressive experience within the GMP and GDP quality function of the pharmaceutical healthcare industry. Experience of working with the BV market will provide a competitive advantage. - Strong communication skills and excellent in English (writing & speaking). - Integrity, able to maintain a balance between commercial decisions and maintaining compliance with quality.
Audit Management Plan, schedule, and coordinate supplier audits (API, CMO, intermediates, and service providers) in line with global quality standards. Maintain supplier audit data, audit schedules, and audit tracking systems. Manage pre-audit preparation, audit conduct, and post-audit follow-up activities. Review and monitor CAPA (Corrective and Preventive Action) plans to ensure timely and effective closure. Support internal and external audit readiness. 2. Supplier Oversight and Communication Maintain consistent communication with Contract Manufacturing Organizations (CMOs), API suppliers, and other partners to ensure compliance with agreed quality standards. Evaluate supplier performance and support supplier qualification and requalification processes. Manage supplier documentation and ensure data integrity within the supplier management database. 3. Compliance and Quality Systems Ensure adherence to GMP, GDP, and other relevant regulatory and corporate compliance requirements. Identify and mitigate risks related to supplier quality and audit management. Support deviation investigations, change controls, and quality risk assessments where applicable. 4. QTA (Quality Technical Agreement) and System Responsibilities Lead and coordinate Quality Technical Agreement (QTA) drafting, review, and maintenance in alignment with corporate templates and regulatory expectations. Manage the supplier module in TrakWise, ensuring data accuracy and timely updates. Collaborate cross-functionally with global QA, procurement, and technical teams for seamless quality governance. Qualifications and Experience: Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or a related field. Experience: 8-10 years of experience in quality assurance, compliance, or supplier audit management within the pharmaceutical or biopharmaceutical industry. Strong understanding of GMP/GDP guidelines, quality systems, and regulatory expectations. Experience with supplier audits, CAPA management, and QTA handling preferred. Hands-on experience with electronic quality management systems (e.g., TrakWise, Veeva, or similar) is an advantage.