We are seeking a highly experienced and knowledgeable
Quality Control Manager
to lead our QC department in a regulated
pharmaceutical formulation manufacturing facility
.
The ideal candidate should have
extensive experience in handling audits such as WHO-GMP, EU-GMP, UK-MHRA, and USFDA
, with in-depth understanding of
Revised Schedule M (2022) requirements
.
Key Responsibilities:
Oversee and manage all
Quality Control activities
for raw materials, in-process samples, finished products, and stability testing.
Ensure all QC operations comply with
cGMP
,
Revised Schedule M
, and
global regulatory standards
.
Supervise analytical testing, instrument calibration, and documentation practices as per ALCOA+ principles.
Review and approve analytical data, COAs, and laboratory records.
Ensure readiness and compliance for audits by
WHO, EU, UK-MHRA, and USFDA
authorities.
Coordinate with
QA, Production, and R&D
to ensure consistent product quality and regulatory compliance.
Drive implementation of laboratory automation and data integrity systems.
Lead, train, and develop QC team members to maintain operational excellence.
Prepare and review SOPs, method validation protocols, and investigation reports.
Monitor OOS/OOT results, CAPAs, and ensure timely closure of quality events.
in Quality Control, with strong exposure to international regulatory audits.
Strong knowledge of
analytical instruments
(HPLC, GC, UV, IR, Dissolution Tester, etc.).
Comprehensive understanding of
Revised Schedule M (2022)
and global GMP guidelines.
Proven ability to manage teams and ensure compliance under pressure.
Excellent communication, leadership, and audit-facing skills.
Job Type: Full-time
Pay: ?50,000.00 - ?80,000.00 per month
Work Location: In person
Beware of fraud agents! do not pay money to get a job
MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.