Senior Executive - DQA

**Job Description:** **Role Overview:** As a Quality Assurance Manager at Piramal Pharma Solutions, you will be responsible for overseeing and supporting the overall activities during the product development life cycle from a quality perspective in R&D (API and intermediates). You will need to understand the site needs concerning system establishment and sustainability and ensure effective implementation of SOPs/work directions as per GLP and regulatory requirements. **Key Responsibilities:** - Author, review, and approve SOPs/work directions required for implementing Quality systems in R&D activities - Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), analytical documents, and stability data - Conduct periodic audits of R&D laboratory and ensure online documentation - Perform cGMP audit of R&D facilities and operations - Provide quality-related inputs to new projects, existing projects, and upgradations - Participate in the identification of key starting material (KSM)/registered starting material (RSM) - Assist in handling OOS, OOT, deviations, batch failures, investigations, and CAPA implementation - Establish raw material standards by studying manufacturing/R&D requirements - Ensure R&D team is trained for their relevant job function and GMP/GLP training - Follow safety and environmental procedures deployed in the site **Qualifications:** - Graduation and above in Science/Pharmacy **Additional Details:** In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth while adhering to ethical and values-driven practices. The company provides equal employment opportunities based on merit, ensuring that all applicants and employees receive equal opportunities in personnel matters. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. The company serves customers globally through a network of facilities in North America, Europe, and Asia, providing services such as drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. PPS also offers specialized services in highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. Additionally, PPS offers development and manufacturing services for biologics, including vaccines, gene therapies, and monoclonal antibodies, making it a preferred partner for innovators and generic companies worldwide.,