QA Specialist

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:

Strong 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!

Skills Required
Qa, Qms