Quality Assurance Manager

Job Description

Company Description

AMN 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 CQA

Position Summary

The Quality Manager will lead and oversee all Quality Assurance (QA) and Quality Control (QC) activities at the formulation plant, ensuring compliance with EU GMP, USFDA, and other global regulatory requirements. The role will focus on generic formulations and -lactam facilities, ensuring highest product quality, regulatory compliance, and continuous improvement.

Key ResponsibilitiesQuality Assurance (QA)

- Ensure compliance with EU-GMP, WHO-GMP, USFDA, MHRA, TGA, CDSCO, and other international regulatory standards.
- Review, approve and maintain SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and master documents.
- Oversee deviations, change controls, CAPA, OOS/OOT investigations, and ensure timely closure.
- Lead internal audits, vendor audits, and regulatory inspections; ensure readiness at all times.
- Manage QMS (Quality Management System) and ensure effectiveness across the site.
- Ensure compliance in cleanroom, microbiological controls, cross-contamination controls specific to -lactam plant operations.
- Oversee qualification & validation activities process validation, cleaning validation, equipment qualification, analytical method validation.
- Drive continuous quality improvement initiatives and implement best practices.

Quality Control (QC)

- Supervise QC operations including raw materials, in-process, finished product, microbiology, and stability studies.
- Ensure laboratory compliance with GLP and regulatory guidelines.
- Oversee method transfers, verification, and troubleshooting of analytical techniques.
- Approve COAs and analytical reports.

Regulatory & Compliance

- Ensure plant operations meet EU dossier requirements and customer specifications for generics.
- Prepare and review regulatory submissions, technical files, and CMC documentation.
- Act as primary contact during regulatory audits/inspections and customer audits.

Leadership & Team Management

- Lead and develop QA/QC teams with strong focus on training and skill enhancement.
- Ensure effective cross-functional collaboration between Production, Engineering, R&D, Regulatory, and Supply Chain.
- Promote a strong quality culture across the site.

Key Skills & Competencies

- In-depth knowledge of EU-GMP, ICH guidelines, GLP, WHO GMP, USFDA regulations.
- Expertise in formulations (OSD, injectables, suspensions, etc.) and -lactam manufacturing processes.
- Strong understanding of sterility assurance, microbiology, and containment strategies for -lactam facilities.
- Proficient in QMS tools (TrackWise, Veeva, or equivalent).
- Strong leadership, decision-making, and problem-solving skills.
- Excellent communication for handling regulatory agencies and global clients.

Qualifications & Experience

- Master's in Pharmacy / Pharmaceutical Sciences / Chemistry (M.Pharm / M.Sc).
- Minimum 1015 years of experience in pharmaceutical QA, with at least 7+ years in a managerial role.
- Hands-on experience in formulations, generics, and -lactam facilities.
- Proven track record of facing EU/MHRA/USFDA inspections.

Salary Range-Not disclosed

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