Manager/ Sr.Manager Quality Assurance (Pharma Industry)

BVR People Consulting

18 - 25 years

15 - 20 Lacs

chennai

Posted:3 days ago| Platform:

Apply

Skills Required

usfda ipqa customer complaints api supplier audit documentation quality assurance quality standards

Work Mode

Work from Office

Job Type

Full Time

Job Description

Qualification & Experience:

Qualification:
M.Sc. Chemistry.
Experience:
16- 25 years in
Quality Assurance within an API or Bulk Drug Manufacturing
environment.
Must have prior exposure to
USFDA and other international audits
.

Role & responsibilities

Lead
In-Process Quality Assurance (IPQA)
activities across production and packaging areas.
Ensure compliance with
USFDA, WHO-GMP, MHRA, and other international regulatory requirements
.
Prepare, review, and approve
QA documents
SOPs, batch records, deviations, CAPA, and change controls.
Plan and coordinate
regulatory and customer audits
, including audit readiness and follow-up actions.
Conduct
supplier audits
and evaluate vendor quality systems for raw materials and intermediates.
Oversee
validation activities
process validation, cleaning validation, equipment qualification, and analytical method validation.
Ensure timely closure of
deviations, OOS/OOT, CAPA, and market complaints
.
Maintain
quality management systems (QMS)
and ensure data integrity compliance.
Guide cross-functional teams in
GMP practices
and continuous improvement initiatives.
Train and mentor the QA team to strengthen regulatory compliance culture.

Required Skills & Competencies:

Strong understanding of
API manufacturing processes
and
GMP regulations
.
In-depth knowledge of
USFDA, WHO, ICH, and other regulatory guidelines
.
Experience in handling
regulatory audits
and customer inspections.
Hands-on experience in
documentation, validation, and QMS implementation
.
Strong analytical, problem-solving, and leadership skills.
Excellent communication and report-writing skills.
Proficiency in using
electronic QMS / document control systems
is an added advantage.

Regards,

Dhivakar D

dhivakar@bvrpc.com

More Jobs at BVR People Consulting

Sr Mgr - Software Engineer (LabView / Teststand) / Female / Bangalore

Bengaluru

6 - 11 yrs

INR 20 - 22 Lacs

Sr Manager - Oracle SCM Consultant (R12) / Female / Bangalore Location

Bengaluru

6 - 11 yrs

INR 16 - 17 Lacs

Talent Acquisition Manager_Leading Manufacturing Company_Hosur

Hosur

12 - 14 yrs

INR 20 - 25 Lacs

Intellectual Property(IPM)_API_Pharmaceutical Company_Chennai

Chennai

2 - 5 yrs

INR 2 - 6 Lacs

RA ANDA_Formulation_Leading Pharmaceutical Company_Chennai

Chennai

8 - 13 yrs

INR 10 - 15 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.