Dy.Manager-Quality Assurance-Hormonal(API)@ Apichem Vangaplli

MSN Group

12 - 15 years

8 - 14 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

IPQA QMS Hormonal API

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Lead the entire
QA function
for
Hormonal API
manufacturing, ensuring compliance with
cGMP, ICH, USFDA, EUGMP
and other regulatory guidelines.
Develop, implement, and review
SOPs
,
quality systems
,
change controls
,
deviations
,
CAPA
, and
risk assessments
specific to hormonal APIs.
Supervise
batch release
,
review of BMRs/BPRs
, and manage document control systems.
Prepare and face
regulatory inspections
(USFDA, WHO, EUGMP, CDSCO, etc.) and client audits independently.
Coordinate with
QC, Production, Engineering, and Regulatory Affairs
to ensure quality compliance across the plant.
Monitor
environmental conditions
and
containment protocols
related to hormonal API handling.
Conduct internal audits and ensure
data integrity
and
compliance
with ALCOA+ principles.
Mentor, train, and guide the QA team to maintain high quality and compliance standards.

Candidate Profile:

B.Pharm / M.Pharm / M.Sc. Chemistry with
1215 years
of experience in
Hormonal API
QA.
Mandatory:
Hands-on experience in handling QA for
Hormonal APIs

Should have independently faced audits and led a QA team.
Strong understanding of
regulatory expectations
, quality systems, and documentation practices.
Excellent leadership, communication, and cross-functional coordination skills

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