Department: Quality Assurance / Quality Control

The Quality Manager will be responsible for ensuring compliance,
quality control, and regulatory adherence at third-party manufacturing
facilities. This role involves auditing and monitoring third-party
manufacturers, ensuring GMP compliance, product quality, and regulatory
standards are met while working closely with production, regulatory, and
supply chain teams. The ideal candidate should have a robust production
background with expertise in quality assurance and control.

Key Responsibilities:

1. Quality Oversight of 3rd Party Manufacturers
- Monitor quality standards at
third-party manufacturing facilities.
- Conduct regular site visits, audits,
and inspections to ensure compliance with cGMP, WHO-GMP, USFDA,
MHRA, and other regulatory guidelines.
- Review and approve batch manufacturing
records (BMRs) and batch packaging records (BPRs).

2. Compliance & Regulatory Audits
- Ensure third-party manufacturers
adhere to quality agreements, SOPs, and regulatory requirements.
- Coordinate with regulatory teams for




dossier submissions, product registrations, and regulatory inspections.
- Manage deviations, OOS (Out of
Specification), OOT (Out of Trend), and CAPA (Corrective and Preventive
Actions) at third-party sites.

3. Quality Control & Product Testing
- Ensure raw material, in-process, and
finished product testing is conducted as per standard specifications.
- Review stability studies, analytical
data, and lab investigation reports.
- Collaborate with analytical labs and
QC teams to ensure product quality compliance.

4. Vendor Qualification & Process Validation
- Conduct vendor qualification, supplier
audits, and performance evaluations.
- Review and approve process validation,
cleaning validation, and analytical method validation reports.
- Work with third-party manufacturers to
optimize processes and improve product quality.

5. Documentation & Reporting
- Maintain quality agreements, technical
agreements, and a

📌 Quality Manager – 3rd Party Manufacturing (Panchkula)
🏢 TalentXplore
📍 Panchkula