Quality Control Manager(Manufacturing/Product Industry)

Genes2me

7 - 10 years

7 - 9 Lacs

gurugram

Posted:1 day ago| Platform:

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Skills Required

diagnostic kits qc molecular diagnostics ivd rt-pcr immunoassay diagnostics quality control management quality management biochemistry laboratory technician molecular medical laboratory technician pre-natal screening maternal screening quality control

Work Mode

Work from Office

Job Type

Full Time

Job Description

About the Role

Key Responsibilities & Skills

Perform hands-on testing and validation using
RT-PCR, Spectrophotometer, pH Meter, Automatic Extraction Systems
, and
Gel Electrophoresis
.
Ensure rigorous
quality control processes
across all IVD products.
Lead quality checks for
Extraction Kits (Silica Column & Magnetic Beads)
and
RT-PCR Kits
(Infectious Diseases, Cancer Markers, etc.).
Develop and maintain
Standard Operating Procedures (SOPs)
and ensure adherence to quality standards.
Prepare
stability study documentation
and manage
clinical sample panels
.
Handle
complaints
, perform
troubleshooting
, and provide mentorship to team members on
OOS (Out of Specification)
results.
Conduct
calibration and validation
of instruments and equipment.
Manage
audit and documentation
activities and support
regulatory registration documents
for overseas markets.
Drive
continuous improvement
in QC methodologies and systems.
Demonstrate strong
leadership, people management
, and
presentation skills
.
Ensure
technical accuracy
in
IFU (Instructions for Use)
documents, including intended use, principles, references, and procedures.

Qualifications

M.Sc.
in
Biotechnology, Microbiology, or Immunology
(Ph.D. preferred).
7–10 years
of Quality Control experience in an
IVD medical device manufacturing environment
.
Strong knowledge of
IVDR (CE Marking) reference standards
and compliance requirements.
Proficient in
MS Office
and laboratory data management systems.
Minimum
7–8 years of experience
with the ability to
lead an existing QC team
effectively.

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