Sr. Manager- R&D Quality (PV-QA)

As a Senior Manager in R&D Quality (Pharmacovigilance Quality Assurance) at Sun Pharmaceutical Industries Ltd in Gurgaon, your primary responsibility will be to implement a well-defined Quality Assurance program in compliance with regional and global regulatory requirements, SOPs, and company policies. You will play a key role in developing and executing global Pharmacovigilance auditing programs, ensuring adherence to established Quality Systems. Your duties will include conducting audits at Sun Pharma sites associated with Pharmacovigilance activities, as well as auditing outsourced parties, affiliates, and partners involved in Pharmacovigilance operations. You will manage the Internal Audit Observation Database (IAOD) and facilitate the harmonization of Quality Systems across all Pharmacovigilance sites. Additionally, you will be responsible for reviewing Pharmacovigilance SOPs, ensuring completeness, clarity, and compliance with global/regional policies and regulatory guidelines. Your role will also involve providing training, updating audit schedules, preparing reports, and overseeing the readiness of Sun Pharma PV sites for regulatory inspections. Furthermore, you will supervise and participate in Taro cases review, validate GxP Computerized Systems, and act as Process Quality Lead for system validation at the R&D Gurugram site. You will review and approve documentation, inventory, system releases, and retirement documents related to computerized systems, ensuring compliance with quality standards. Your educational background should include a Post Graduate degree in Pharmacy (M. Pharma) or Pharmacology, along with approximately 15 years of relevant experience. Technical competencies required for this role include strong auditing skills. In terms of behavioral competencies and soft skills, proficiency in spoken and written English, people management, and effective collaboration with different teams are essential qualities for success in this position. Overall, as a Senior Manager in R&D Quality (Pharmacovigilance Quality Assurance) at Sun Pharmaceutical Industries Ltd, you will play a crucial role in ensuring the quality and compliance of Pharmacovigilance operations, contributing to the overall success of the company's R&D Quality department.,