Quality Assurance Manager

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
β-lactam facilities
, ensuring highest product quality, regulatory compliance, and continuous improvement.

Key Responsibilities
Quality 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
  β-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
  β-lactam manufacturing processes
  .
• Strong understanding of
  sterility assurance, microbiology, and containment strategies for β-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
  10–15 years of experience
  in pharmaceutical QA, with at least 7
  + years in a managerial role
  .
• Hands-on experience in
  formulations, generics, and β-lactam facilities
  .
• Proven track record of facing
  EU/MHRA/USFDA inspections
  .

Salary Range-Not disclosed

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