Manager-Quality Assurance

Roles & Responsibilities:
• Review and approve SOPs, calibration, maintenance, and qualification/validation documents
• Review URS, impact assessment, risk management, validation protocols, reports, and VMP
• Review executed DQ, IQ, OQ, PQ documents and ensure compliance with SOPs
• Ensure qualification and validation activities meet regulatory and GMP requirements
• Participate in global QA and regulatory inspections; draft responses and collect evidence
• Review and approve deviations, OOS/OOT, change controls, and CAPAs
• Ensure timely closure of quality records and perform gap assessments
• Manage document control and archival of master documents
• Conduct internal audits and monitor vendor performance and quality agreements
• Conduct GMP and quality training and ensure no overdue trainings
• Ensure data integrity compliance and implement safety-related CAPAs

Qualifications:
• Bachelor’s degree in Pharmacy or Master’s degree in Chemistry

Experience:
• 12–15 years in Quality Assurance within pharmaceutical or API manufacturing

Skills:
• Strong knowledge of cGMP, FDA, ICH, and EU GMP guidelines
• Quality Management Systems (QMS) and auditing expertise
• Equipment calibration, utilities, and supplier management
• Root Cause Analysis and Quality Risk Management (FMEA)
• Data integrity and electronic systems exposure
• Strong communication, leadership, and problem-solving skills

Preferred Skills:
• Laboratory compliance
• SCADA / DCS systems
• LIMS

About the Organization:
Ferring India Production is part of Ferring Pharmaceuticals, a global biopharmaceutical company committed to quality excellence, regulatory compliance, and patient safety across its manufacturing and quality operations.