Senior Quality Assurance Specialist

Position SummaryThe Senior QA/QC Specialist ensures that all pharmaceutical drug products are manufactured, tested, and released in strict compliance with U.S. FDA 21 CFR Parts 210/211 (cGMP) and relevant ICH guidelines. This role acts as a bridge between production and regulatory compliance, leading investigations, managing the Corrective and Preventive Action (CAPA) system, and preparing for regulatory inspections (RA). LinkedIn India +1Key ResponsibilitiesQuality System Management (QA): Maintain and update the Quality Management System (QMS), including Standard Operating Procedures (SOPs), change controls, and deviation management to ensure cGMP compliance.CAPA & Investigations: Lead investigations for manufacturing deviations, OOS (Out of Specification) results, and customer complaints using root cause analysis tools (e.g., Fishbone, 5 Whys). Define, track, and verify effectiveness of Corrective and Preventive Actions.Regulatory Affairs (RA) Support: Assist in regulatory inspections (FDA, EMA), draft responses to inspection observations (Form 483), and maintain documentation for regulatory dossiers.Batch Release: Review and approve batch production records (BPR), lab testing records, and analytical data to ensure compliance before product release.Manufacturing Oversight: Provide on-floor QA oversight, ensuring adherence to GMP during production, packaging, and sampling.Risk Management & Audits: Perform internal audits and supplier audits. Participate in risk assessments (FMEA) to identify and mitigate quality risks. LinkedIn India +8Requirements (Experience & Knowledge)Education: Bachelor’s degree in Chemistry, Pharmacy, Biology, or related life science discipline.Experience: Minimum 5–8+ years of experience in QA/QC within a pharmaceutical manufacturing environment (FDA regulated).Regulatory Knowledge: Deep understanding of USA CFR 21 Parts 11, 210, and 211 (cGMP).CAPA/RA Skills: Demonstrated hands-on experience in managing deviations, change control, and CAPA systems. Experience supporting regulatory inspections (FDA).Technical Writing: Excellent technical writing skills for SOPs, investigation reports, and audits.Tools: Proficient in QMS software, Electronic Batch Records (EBR), and Microsoft Office. Key CompetenciesAttention to Detail: Ability to meticulously review records for data integrity.Problem-Solving: Proven ability to identify root causes and implement effective solutions.Collaboration: Strong interpersonal skills to work with Production, QC, and Regulatory departments.