QA Specialist

Life Infusion Pharmaceuticals Pvt. Ltd., a GMP-certified IV fluid manufacturing company located at Kinaloor, Balussery, Kozhikode, is hiring a QA Manager/Specialist for our sterile injectable (SVP) manufacturing operations.

Qualification: B.Pharm / M.Pharm / M.Sc (Chemistry, Microbiology, or Life Sciences)

Experience: 2–5 years in Injectable/Sterile manufacturing, preferably SVP

Key Responsibilities:

• Lead and manage overall QA activities for Injectable / SVP manufacturing operations
• Ensure compliance with cGMP, regulatory requirements, SOPs and company quality standards
• Oversee IPQA activities across manufacturing and packing operations
• Ensure effective line clearance, in-process checks and batch documentation review
• Review and approve BMR/BPR and other GMP-related documents
• Manage and review deviations, OOS/OOT, CAPA, change controls and quality investigations
• Ensure implementation and monitoring of Environmental Monitoring requirements for sterile areas
• Oversee QA activities related to aseptic processing, filling, sterilization and sterile manufacturing operations
• Ensure compliance with cleanroom practices, contamination control and aseptic practices
• Support media fill / aseptic process simulation activities
• Review and ensure compliance of water systems, HVAC and other critical utility-related QA requirements
• Coordinate with Production, QC, Engineering, Microbiology and other departments for quality-related activities
• Prepare the facility and team for regulatory inspections, customer audits and internal audits
• Ensure timely implementation and closure of CAPA and audit observations
• Promote a strong Quality Culture and Data Integrity across the organization
• Lead, train and develop the QA team to ensure effective performance

Skills Required:

• Strong experience in Injectable / Sterile manufacturing, preferably SVP
• Hands-on experience in QA operations and pharmaceutical Quality Management Systems
• Sound knowledge of cGMP, Schedule M and regulatory requirements
• Strong documentation, investigation and analytical skills
• Good communication and team leadership skills

Job Type: Full-time

Location: Kinaloor, Balussery, Kozhikode, Kerala

Pay: ₹20,000.00 - ₹80,000.00 per month

Ability to commute/relocate:

• Balusseri, Kerala: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Master's (Preferred)

Experience:

• in Injectable/Sterile manufacturing, preferably SVP: 2 years (Required)

Work Location: In person