Deputy Manager-QA

Job Description

To ensure that all the computerized systems meeting the 21 CFR part11, EU ANNEX 11and GAMP5 guidelines requirements. Involvement during the computerized system validations and there by reviewing the validation documents. Coordinating with corporate QeC & IT teams to implement best practices with ITC Governance initiatives and corporate policies. Providing support in periodic assessments to ensure the compliance of defined IT related SOP‘s and procedures of computerized systems. Performing investigations related to computerized systems, there by identifying the root cause and making sure that adequate CAPA is in place. Responsible for review of IT supplier assessment and ensure that all the software’s are in compliance. Involving and providing support during customer and regulatory audits. Responsible for handling Data Integrity (DI) initiatives at site. Responsible to perform internal self & DI audits for IT related systems. To conduct trainings on computer system validation, 21 CFR part11, EU ANNEX 11 and GAMP5 guidelines for site teams. Responsible for review of SOP’s related to IT systems. Responsible for review of change controls and deviations related to IT systems. Coordinates with all functional departments to do uninterrupted GMP and 21 CFR Part 11 implementations and report the concerns/status on day today basis to reporting manager. In my absence, responsible manager shall take care of my responsibilities. Any other works allotted by the Head – Quality / QA / Designee on day to day basis. 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. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. 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. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.