Business PPL Department Quality Assurance Location Navi Mumbai Travel Low Job OverviewLead and oversee GMP-compliant quality systems for a peptide API facility including equipment qualification CSV vendor and contract lab qualification training management and document control ensuring regulatory compliance data integrity and inspection readiness Key Stakeholders InternalOperations Engineering QC IT and Supply Chain Key Stakeholders External Vendors External Service Providers Reporting Structure Head - Quality Assurance Experience 10-15 years in QA within API Peptide Pharmaceutical manufacturing Key Responsibility 1 Equipment Qualification CSVo Provide overall leadership and strategic oversight for DQ IQ OQ and PQ activities covering manufacturing laboratory utilities and critical support equipment o Ensure qualification activities are planned and executed using a risk-based approach in full compliance with GMP and data integrity requirements o Lead and govern Computer System Validation CSV for all GxP-critical computerized systems o Review approve and ensure adequacy of qualification validation protocols reports deviations and change controls o Actively support and drive the site digitization and automation initiatives as part of the Site Improvement Plan 2 Vendor External Party Qualification o Establish and maintain systems for Vendor Qualification for raw materials o Lead Contract Laboratory Qualification including technical assessment documentation review and audit oversight o Qualify and monitor external service providers calibration validation maintenance testing and consulting agencies o Support supplier audits and regulatory inspections related to vendor management 3 Training Management System o Own and manage the training lifecycle for GMP SOPs equipment systems and job-specific competencies o Ensure training matrices are established maintained and periodically reviewed o Support audit-ready documentation for internal customer and regulatory inspections 4 Documentation Issuance Control o Lead and oversee document control systems including SOPs protocols formats manuals and quality records o Ensure controlled issuance revision archival and retrieval of GMP documents o Review and approve quality documents in alignment with site quality policies o Ensure compliance with ALCOA and data integrity principles 5 Quality Systems Compliance o Support deviation management CAPA change control OOS OOT and risk assessments related to qualification and validation activities o Participate in internal audits vendor audits and regulatory inspections o Provide quality guidance to cross-functional teams and ensure timely closure of audit observations 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 opportunityPiramal 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 advantages 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