Quality Assurance (AQA/IPQA/QMS)

Roles & Responsibilities
• Handle Quality Management System (QMS) activities including OOS, OOT, deviations, CAPA, change control, and investigations
• Support Analytical Quality Assurance activities such as lab event handling, QC instrumentation oversight, and laboratory compliance monitoring
• Ensure implementation and monitoring of Data Integrity principles (ALCOA+) across QA and QC operations
• Perform IPQA activities during manufacturing and packaging processes
• Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)
• Maintain compliance with cGMP and Good Documentation Practices (GDP)
• Support internal and external regulatory audits and ensure audit readiness
• Conduct GMP/QMS training programs and risk assessments
• Coordinate with cross-functional teams to ensure smooth quality and compliance operations
• Monitor and support manufacturing and laboratory quality improvement initiatives

Qualification
• M.Pharm / B.Pharm / M.Sc (Organic Chemistry)

Experience
• 6 to 8 years of relevant experience in Quality Assurance
• Experience in injectables or sterile pharmaceutical manufacturing preferred

Skills Required
• Strong knowledge of GMP, GDP, and regulatory compliance
• Expertise in handling OOS, OOT, deviations, CAPA, and change control
• Sound understanding of Data Integrity (ALCOA+) principles
• Experience in audit preparation and regulatory inspections
• Good analytical, documentation, and investigation skills
• Strong communication and teamwork abilities

About the Organization
Zenotech Laboratories Limited (Sun Pharma Group), a leading injectables manufacturing organization and a subsidiary of Sun Pharmaceutical Industries, is inviting experienced professionals to join its Quality Assurance team at the Hyderabad facility. The company operates in highly regulated markets and is known for maintaining global quality and compliance standards in sterile and injectable manufacturing.