Business: PPL
Department: Quality Assurance
Location: Navi Mumbai
Travel: Low
Lead 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: Internal
Operations, 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 & CSV
•Provide overall leadership and strategic oversight for DQ, IQ, OQ, and PQ activities covering manufacturing, laboratory, utilities, and critical support equipment.
•Ensure qualification activities are planned and executed using a risk-based approach, in full compliance with GMP and data integrity requirements.
•Lead and govern Computer System Validation (CSV) for all GxP-critical computerized systems.
•Review, approve, and ensure adequacy of qualification/validation protocols, reports, deviations, and change controls.
•Actively support and drive the site digitization and automation initiatives as part of the Site Improvement Plan.
2. Vendor & External Party Qualification
•Establish and maintain systems for Vendor Qualification for raw materials. •Lead Contract Laboratory Qualification, including technical assessment, documentation review, and audit oversight. •Qualify and monitor external service providers (calibration, validation, maintenance, testing, and consulting agencies). •Support supplier audits and regulatory inspections related to vendor management.
3. Training Management System
•Own and manage the training lifecycle for GMP, SOPs, equipment, systems, and job-specific competencies. •Ensure training matrices are established, maintained, and periodically reviewed. •Support audit-ready documentation for internal, customer, and regulatory inspections.
4. Documentation Issuance & Control
•Lead and oversee document control systems including SOPs, protocols, formats, manuals, and quality records. •Ensure controlled issuance, revision, archival, and retrieval of GMP documents. •Review and approve quality documents in alignment with site quality policies. •Ensure compliance with ALCOA+ and data integrity principles.
5. Quality Systems & Compliance
•Support deviation management, CAPA, change control, OOS/OOT, and risk assessments related to qualification and validation activities. •Participate in internal audits, vendor audits, and regulatory inspections. •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 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.
- Offices in over 30 countries
- Brand presence in over 100 global markets
- Team of over 10,000 people from 21 diverse nationalities
Piramal Group is a global business conglomerate with diverse interests in Pharma, Financial Services, and Real Estate. The Group has offices in over 30 countries and a global brand presence in more than 100 markets.
Led by Mr Ajay Piramal, the Chairman, Piramal Group is a torchbearer of trusteeship and responsible business ethos. Based on the philosophy of ‘Doing Well and Doing Good’, the Group continues to create long-term value for its stakeholders and the community at large.
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.
Piramal Foundation, the philanthropic arm of the Piramal Group develops innovative solutions to resolve issues that are critical roadblocks towards unlocking India’s economic potential. Its sustainable development programmes in healthcare & nutrition, education and safe drinking water across 25 Indian states, largely in partnership with the central and state governments have impacted over 100 Million lives till date.
Each social initiative nurtured by the Piramal Foundation addresses one of the three focus areas :
Piramal Swasthya: Primary Healthcare and Nutrition
Piramal School of Leadership: Education Leadership and Women & Youth Empowerment
Piramal Sarvajal: Access to Safe Drinking Water
