Pharmaceutical Quality Systems Manager

Job Description : Quality Assurance Manager

Location : Ludhiana

Company : Gursimar Pharma Pvt. Ltd.

Project Stage : Greenfield – Facility under setup (WHO-GMP compliant)

Department : Quality Assurance

Reporting To : Director

Role Summary

You will lead the establishment of the entire QA framework for a new pharmaceutical formulation manufacturing facility. This role is suited for someone who can build systems from zero, guide validation activities, ensure regulatory compliance from day one, and support the organization through pre-inspection readiness, scale-up, and routine operations.

Your mandate is to design, implement, and maintain QA systems that are compliant, practical, and aligned with WHO-GMP, Schedule-M, and global quality expectations.

Key Responsibilities

1. Quality Systems Setup & Governance

• Establish all QA SOPs, policies, templates, logs, and documentation structures for a new facility.
• Build and operationalise QMS modules : Change Control, CAPA, Deviation, OOS, OOT, Market Complaint, Recall, Supplier Qualification, etc.
• Ensure document control system (manual or digital) is implemented and adhered to.

2. Regulatory Compliance

3. Qualification & Validation

4. Batch Release & Documentation Review

5. Vendor & Material Quality

6. IPQA & Shopfloor Oversight

7. Training & Team Development

8. Risk Management

Required Qualifications & Experience

Skills & Competencies

How to Apply

Interested candidates may apply by sending the following documents via email :

Email your application to : gursimarpharma@gmail.com

Subject Line : Application – QA Manager