Required Corporate QA Manager/Sr.Manager - Pharma (API)

Exemed

10 - 15 years

12 - 20 Lacs

vadodara

Posted:2 days ago| Platform:

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Skills Required

analytical method validation internal audit cqa team audit compliance corporate qa glp global regulatory usfda ich q7eu gmp part ii audit principles ema gmp guidelines usfda expectations alcoa technology transfers pmda

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title:

Department:

Preferred candidate profile

Responsible for harmonizing Quality Systems across sites, ensuring regulatory compliance (USFDA, EMA, ICH Q7, EU GMP Part II), managing audits, and driving data integrity and continuous improvement across the organization.

Key Responsibilities:

Harmonize and oversee quality systems across all API manufacturing sites as per global GMP requirements.
Maintain compliance with regulatory guidelines and support audit readiness.
Conduct routine site inspections and manage external regulatory & customer audits.
Review and approve validation documents, master documents, BMRs, and quality-critical records.
Ensure adherence to ALCOA+ and data integrity principles.
Perform customer audits and manage vendor qualifications and quality agreements.
Support Production, QC, and Engineering in resolving quality issues.
Participate in technology transfers and new product introductions from a QA perspective.
Lead, mentor, and train the CQA team across sites.
Monitor global regulatory updates and ensure alignment across all facilities.

Qualifications:

B.Pharm / M.Pharm / M.Sc. in Life Sciences.
1018 years in QA for API manufacturing, with experience in USFDA-approved sites.
Strong knowledge of ICH Q7, EU GMP Part II, and USFDA expectations.

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