Senior Executive - Quality (Loan Licensing)

Role Overview: You will be responsible for monitoring the Loan License Site located in Navi Mumbai, specifically focusing on IPQA/Shop floor activities related to Tablets, Capsules, Oral Liquids, External and Sterile formulations. Your role will involve overseeing quality at Loan License Sites, conducting FG inspections, reviewing batch records, and ensuring batch releases. Additionally, you will be involved in site pre-assessment for regulatory inspections, investigation of non-compliance issues, and review of COA and analytical data before releasing finished products. Key Responsibilities: - Monitor IPQA/Shop floor activities for various formulations - Provide quality oversight at Loan License Sites and ensure closure of actions - Conduct FG inspections, review batch records, and release batches - Assist in site pre-assessment for regulatory inspections - Investigate non-compliance issues and track closure of CAPA - Review COA and analytical data prior to releasing finished products - Review finished product data to support new product launches - Execute process validation and stability studies, and review data at Loan License Unit (LLU) - Prepare APQR, witness manufacturing, and analyze finished products - Conduct quality audits of Contract Manufacturers and review compliance - Manage LLU operations and coordinate activities Qualification Required: - B. Pharmacy, M. Pharmacy, or any science graduate with relevant experience Additional Details: The ideal candidate should have a good understanding of GMP environment and regulatory inspections. Flexibility for business travel across India and overseas locations is required. Candidates should have experience working on the shop floor with exposure to GMP/GLP practices. Strong decision-making skills, cross-functional collaboration, and effective communication with external stakeholders are essential for this role. Competencies: - Thorough knowledge of shop floor operations for OSD, External, Oral Liquid & Sterile formulations - Experience in handling contract manufacturing sites,