Quality Assurance Manager

Company DescriptionAMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and Kala Amb (Himachal Pradesh), AMN Life is equipped to handle large scale production and tech transfer projects. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, UK, Australia, and Philippines, AMN Life excels in providing quality medicines at affordable prices globally. We are recognized for our strong global presence, innovative R&D, and impeccable on-time delivery record over the past 20 years.Location:Kala Amb ( Himachal Pradesh) Department:Quality Assurance Reports To:Head – CQAPosition SummaryThe Quality Manager will lead and oversee all Quality Assurance (QA) and Quality Control (QC) activities at the formulation plant, ensuring compliance withEU GMP, USFDA, and other global regulatory requirements . The role will focus ongeneric formulationsandβ-lactam facilities , ensuring highest product quality, regulatory compliance, and continuous improvement.Key ResponsibilitiesQuality Assurance (QA)Ensure compliance withEU-GMP, WHO-GMP, USFDA, MHRA, TGA, CDSCO, and other international regulatory standards . Review, approve and maintainSOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs) , and master documents. Overseedeviations, change controls, CAPA, OOS/OOTinvestigations, and ensure timely closure. Leadinternal audits, vendor audits, and regulatory inspections ; ensure readiness at all times. ManageQMS (Quality Management System)and ensure effectiveness across the site. Ensure compliance incleanroom, microbiological controls, cross-contamination controlsspecific toβ-lactam plant operations . Overseequalification & validation activities– process validation, cleaning validation, equipment qualification, analytical method validation. Drivecontinuous quality improvement initiativesand implement best practices. Quality Control (QC)Supervise QC operations includingraw materials, in-process, finished product, microbiology, and stability studies . Ensure laboratory compliance withGLPand regulatory guidelines. Oversee method transfers, verification, and troubleshooting of analytical techniques. Approve COAs and analytical reports. Regulatory & ComplianceEnsure plant operations meetEU dossier requirementsand customer specifications for generics. Prepare and reviewregulatory submissions, technical files, and CMC documentation . Act as primary contact duringregulatory audits/inspectionsand customer audits. Leadership & Team ManagementLead and develop QA/QC teams with strong focus on training and skill enhancement. Ensure effective cross-functional collaboration betweenProduction, Engineering, R&D, Regulatory, and Supply Chain . Promote a strongquality cultureacross the site. Key Skills & CompetenciesIn-depth knowledge ofEU-GMP, ICH guidelines, GLP, WHO GMP, USFDA regulations . Expertise informulations (OSD, injectables, suspensions, etc.)andβ-lactam manufacturing processes . Strong understanding ofsterility assurance, microbiology, and containment strategies for β-lactam facilities . Proficient inQMS tools(TrackWise, Veeva, or equivalent). Strong leadership, decision-making, and problem-solving skills. Excellent communication for handlingregulatory agencies and global clients . Qualifications & ExperienceMaster’s inPharmacy / Pharmaceutical Sciences / Chemistry(M.Pharm / M.Sc). Minimum10–15 years of experiencein pharmaceutical QA, with at least 7 + years in a managerial role . Hands-on experience informulations, generics, and β-lactam facilities . Proven track record of facingEU/MHRA/USFDA inspections .Salary Range-Not disclosedPlease feel free to connect @8976869261 and share your CV atshankar.sahu@amnlife.com/hr@amnlife.com