Quality Assurance Manager(API)

Acme Services

16 - 26 years

2 - 5 Lacs

Thane Maharashtra India

Posted:10 hours ago| Platform: Foundit logo

Apply

Skills Required

GMP-compliant quality systems Gmp ICH guidelines regulatory inspections

Work Mode

On-site

Job Type

Full Time

Job Description

Key Responsibilities:

Establish, implement, and maintain
GMP-compliant quality systems
across the API manufacturing unit.
Lead and participate in
regulatory, internal, and third-party audits
; ensure timely closure of observations and CAPAs.
Review and approve
validation protocols, master documents, and batch records
in line with regulatory requirements.
Oversee
product release
, stability studies, and quality documentation control.
Manage and investigate
market complaints
and implement appropriate corrective actions.
Ensure
regulatory compliance
with international guidelines (e.g., USFDA, EU-GMP, WHO-GMP).
Handle
vendor audits and qualification
for raw materials, packaging materials, and third-party manufacturers.
Train and guide the QA team to ensure continuous improvement and inspection readiness.

Required Skills & Qualifications:

Bachelor's/Master's degree in Pharmacy, Chemistry, or a related field.
812 years of experience
in
QA roles within API manufacturing
, including managerial experience.
Strong understanding of
GMP
,
ICH guidelines
, and international regulatory frameworks.
Proven experience with
regulatory inspections
(USFDA, MHRA, EUGMP, etc.).
Excellent leadership, documentation, and communication skills.

More Jobs at Acme Services

Sourcing executive

Mumbai

1 - 4 yrs

INR 0 - 3 Lacs

Article Assistant

Mumbai, Mumbai Suburban, Bangalore Rural, Bengaluru, Mumbai (All Areas)

Experience: Not specified

INR 0 - 0 Lacs

Tax Manager

Mumbai, Maharashtra, India

5 - 8 yrs

Salary: Not disclosed

Key Account Manager - QuickCommerce

Gurugram, Haryana, India

3 - 5 yrs

Salary: Not disclosed

Customer Care Executive

Powai, Mumbai, Maharashtra

Experience: Not specified

INR 0 - 0 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.