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Manager - Quality Assurance

Piramal Enterprises
Thane, India
10-15 Years
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  • Posted a month ago
  • Over 50 applicants

Job Description

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
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.

More Info

Job Type:
Permanent Job
Industry:
Pharmaceutical
Function:
Quality Assurance
Employment Type:
Full time

About Company

Piramal Enterprises

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.

Job ID: 140334177

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Last Updated: 15-03-2026 06:27:34 AM
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