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 robust Quality Culture and Data Integrity across the organization
Lead, train and develop the QA team to ensure effective performance

Skills Required:
Solid 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

📌 Qa Specialist Balussery
🏢 LifeInfusion Pharmaceuticals PvtLtd.,
📍 Balussery