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

Please feel free to connect @8976869261 and share your CV at

shankar.sahu@amnlife.com / hr@amnlife.com