Senior Executive - DQA

Role Overview: 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). Your role will involve understanding the site needs for system establishment and sustainability, authoring/reviewing/approving SOPs/work directions, and ensuring effective implementation of quality systems in R&D activities as per GLP and regulatory requirements. Additionally, you will be required to review and approve various reports, conduct periodic audits of the R&D laboratory, ensure effective maintenance of records, and perform cGMP audits of R&D facilities and operations. Training the R&D team for their relevant job functions and providing quality-related inputs to projects will also be part of your responsibilities. Key Responsibilities: - Oversee and support activities during the product development life cycle in R&D from a quality perspective - Understand site needs for system establishment and sustainability - Author, review, and approve SOPs/work directions for implementing quality systems in R&D activities - Review and approve various reports such as Lab Familiarization Reports, Product development reports, etc. - Conduct periodic audits of R&D laboratory and ensure online documentation - Maintain R&D records, distribution, and archival systems - Perform cGMP audits of R&D facilities and operations - Train R&D team for their job functions and provide quality-related inputs to projects - Participate in handling deviations, investigations, and CAPA implementation - Establish raw material standards by studying manufacturing/R&D requirements - Follow safety and environmental procedures deployed in the site Qualifications: - Graduation and above in Science/Pharmacy About the Company: 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, considering qualifications, skills, performance, and achievements. Piramal Group is committed to ensuring equal opportunity in personnel matters for all applicants and employees, including recruitment, selection, training, promotion, compensation, and working conditions. About the Team: 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 development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. PPS also offers specialized services for highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products, and potent solid oral drug products. Additionally, PPS provides services for biologics including vaccines, gene therapies, and monoclonal antibodies. With a track record as a trusted service provider, Piramal Pharma Solutions is a partner of choice for innovators and generic companies worldwide.,