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