Job Description for a Quality Assurance (QA) Manager
Department
: Quality Assurance
Location
: Surendranagar
Reporting To
: Head – Plant QA
Job Responsibilities
:
Ensure adherence to
Good Documentation Practices (GDP)
and
Good Manufacturing Practices (GMP)
across the site.
Responsible for
Document Control Cell
including review, draft circulation, finalization, and preparation of master documents.
Maintain and continuously improve the
Quality Management System (QMS)
.
Verify and implement
Standard Operating Procedures (SOPs)
in QA and coordinate implementation in other departments.
Review master documents such as
Site Master File (SMF)
,
Validation Master Plan (VMP)
, and
Quality Manual (QM)
.
Coordinate and oversee
validation activities
, including process, cleaning, and equipment validations.
Handle
Change Controls
,
Deviations
,
Out of Specification (OOS)
,
Out of Trend (OOT)
,
Market Complaints
,
Corrective and Preventive Actions (CAPA)
, and
Nonconformities
, in coordination with relevant departments.
Review and approve
qualification and validation protocols/reports
.
Actively participate in the development, maintenance, and updates of the company’s
Quality Manual
.
Plan, coordinate, and implement
internal audits
,
vendor audits
, and
quality training programs
.
Review
QMS trends
and
Annual Product Quality Review (APQR)
.
Conduct
on-the-job training
for personnel from Production, Stores, Engineering, and QC departments.
Manage the
review and control of BMR/BPR
and coordinate for
batch release
for dispatch.
Serve as the
QA Lead in the absence of the Head – Plant QA
, ensuring continuity of all QA functions.
Qualifications
:
B.Pharm / M.Pharm / M.Sc.
Strong knowledge of cGMP, QMS, and regulatory requirements
Audit handling and cross-functional coordination skills
