Job Description

Business: PPL


Department: Quality Assurance


Location: Navi Mumbai


Travel: Low

Job Overview

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

o 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 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.