2.0 - 6.0 years

0 Lacs

vadodara, gujarat

On-site

As a QMS Specialist at Pharmanovia, you will play a crucial role in supporting the effective operation, maintenance, and continuous improvement of the global Quality Management System (QMS). Your responsibilities will include ensuring quality compliance across all GxP activities, contributing to the design and implementation of quality systems, monitoring quality processes, and providing oversight across business functions. You will report directly to the Associate Director Internal Quality System and be expected to have a broad understanding and experience of QMS requirements, operation, and compliance in a GMP and GDP environment. Key Responsibilities: - Maintain and update controlled quality documents such as SOPs, policies, and templates - Support and oversee deviation investigations and CAPA lifecycle management - Review and oversee change control records, ensuring regulatory compliance - Act as the primary contact for Computerized Systems (CS) compliance and life cycle management - Administer TrackWise Digital EQMS software to support the effective operation of the QMS - Monitor the GxP training system and maintain training compliance and records - Participate in internal audits and support audit readiness for external audits - Coordinate document and data archiving processes in alignment with data integrity standards - Compile and analyze quality metrics for reporting in QA and Management Reviews - Assist with cross-functional quality risk assessments - Contribute to continuous improvement initiatives and support harmonization efforts across affiliates - Liaise with cross-functional teams to ensure QMS compliance - Maintain awareness of relevant GxP requirements and emerging regulatory expectations - Coordinate and maintain oversight of Product Quality Complaint investigations - Perform other QA related activities as required to support the department or business Qualifications Required: - Bachelor's degree in life sciences or related field, or equivalent relevant experience - At least two years of experience in a GxP-regulated Quality role - Proven experience in Computerized System implementation - Practical experience with QMS elements such as document control, deviations/CAPA, change control, training, complaints, and audit support - Familiarity with EU/UK GMP, GDP, Annex 11, and exposure to Swiss or ICH frameworks - Experience in a multi-entity or virtual operating model - Exposure to TrackWise, Veeva, or other electronic QMS platforms - Experience supporting inspections from regulatory bodies - Strong attention to detail, organizational skills, and ability to work independently - Problem-solving mindset and ability to interpret regulations pragmatically - Excellent verbal and written communication skills - Proficient in IT skills across MS packages including Excel, Word, PowerPoint, Outlook, and Teams Join Pharmanovia to be part of a dynamic, fast-growing international pharmaceutical company that aims to improve patient health globally through the revitalization of niche, tried-and-trusted medicines. As a valued team member, you will have the opportunity to contribute to the company's mission while enjoying a competitive salary, bonus, holiday, health & wellbeing program, employee recognition awards, social events, pension scheme, and hybrid working environment.,

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