QA Officer - Pharma

Roles & Responsibilities
• Actively participate in and ensure compliance during client audits, regulatory audits, and self-inspections
• Handle and maintain QMS documents including Change Control, Incident, Deviation, CAPA, OOS, Recall, Cleaning Validation, and Market Complaints, along with annual trend analysis
• Prepare, review, revise, and implement SOPs and related formats as required
• Prepare and update Site Master File, Validation Master Plan, and Quality Manual
• Provide induction and scheduled training to new and existing employees and define job responsibilities
• Review APQR (Annual Product Quality Review) and technology transfer documents
• Review PV, Hold Time studies, BMR, BPR, Specifications, MOA, Stability Protocols, and Stability Schedules
• Approve artwork for cartons, foils, leaflets, shippers, and packaging materials
• Perform ERP entries including master formula verification, RM/PM master data creation, artwork uploads, batch creation, and procurement planning
• Monitor and control document control room activities including issuance, retrieval, storage, and obsolescence management
• Monitor stability chambers, BOD chambers, pest control activities, and environmental conditions
• Conduct in-process checks during dispensing, granulation, blending, compression, coating, capsule filling, and packing stages
• Perform line clearance at each manufacturing and packing stage
• Conduct sampling for in-process, stability, validation, hold time, cleaning validation, swab/rinse samples, and control samples
• Review and release microbial limit test reports
• Perform AQL checks at compression, coating, inspection, and packing stages
• Monitor rejection handling, batch closing, batch number review, and batch stage-wise BMR review
• Monitor environmental monitoring records, equipment logbooks, and usage logs
• Ensure proper cleaning and monitoring of manufacturing areas, drains, washrooms, and IPQA areas
• Handle calibration of IPQC instruments
• Verify 2D codes, shipper labels, and status labels for areas, materials, and equipment
• Review inspection and destruction of control samples as per SOP
• Release batch and approve documents in absence of Head QA/Asst. Manager

Qualification
• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy) / B.Sc / M.Sc (Relevant Life Sciences Discipline)

Experience
• 2–5+ years of experience in QA/IPQA within pharmaceutical manufacturing
• Hands-on experience in tablet, capsule, and dry powder suspension manufacturing preferred
• Experience in ERP systems and regulatory compliance environment

Skills
• Strong knowledge of GMP, QMS, and regulatory requirements
• Good documentation and audit handling skills
• Attention to detail and compliance-focused mindset
• Ability to work in cross-functional manufacturing environment
• Strong analytical and problem-solving skills
• Effective communication and coordination abilities

About the Organization
TNS Pharma Private Limited is a pioneering pharmaceutical manufacturing company engaged in producing high-quality tablets, capsules, and dry powder suspensions. Established under the umbrella of Trident Lifeline Limited, the organization carries forward a strong legacy of expertise and innovation in the pharmaceutical industry. With a focus on regulatory compliance, quality excellence, and advanced manufacturing practices, TNS Pharma Private Limited is committed to delivering reliable and effective healthcare solutions.