We are hiring a QA Specialist (QMS Activities) for a leading multinational pharmaceutical company at their Ambernath (Mumbai) office. The ideal candidate will play a key role in ensuring compliance with cGMP, FDA, ICH guidelines, and EU GMPs while driving continuous improvement in warehouse and engineering processes.

Key Responsibilities:

Regulatory Compliance & QMS Implementation

- Ensure adherence to cGMP, FDA, ICH guidelines, and EU GMPs.
- Manage document control, deviation management, change control, risk management, and other QMS elements related to warehouse and engineering processes.
- Oversee equipment calibration, preventive maintenance, and utilities, including water systems and nitrogen generation systems.
- Monitor and qualify suppliers, ensuring compliance with technical and regulatory requirements.

Auditing & Risk Management

- Conduct internal audits to assess compliance with quality standards and regulatory requirements.
- Perform Root Cause Analysis (RCA) using tools like A3 PPS, 6M/Cause & Effect (Fishbone), 5 Whys, and Fault Tree Analysis.




- Lead Quality Risk Management (QRM) initiatives using ICH Q9, FMEA, and risk matrices to mitigate risks in warehouse and engineering operations.

Technology & Data Integrity

- Work with ERP/SAP and QMS software for inventory management, document control, deviation management, CAPA tracking, and learning management.
- Ensure data integrity compliance as per regulatory expectations.

Required Skills & Experience:

Solid knowledge of regulatory requirements in pharmaceutical manufacturing.

Hands-on experience in QMS implementation for warehouse and engineering processes.

Expertise in internal audits, RCA methodologies, and risk management tools.

Proficiency in quality management software, ERP/SAP systems, and data integrity principles.

Excellent problem-solving, analytical, and communication skills.

Join a global leader in pharmaceuticals and contribute to ensuring top-quality standards in manufacturing!

📌 QA Specialist (Secunderabad)
🏢 TopGear Consultants Private
📍 Secunderabad