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QC Manager

QC Manager

CellBios

7 - 12 years

9 - 14 Lacs

Chennai

Posted:4 months ago| Platform:

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Skills Required

Product quality ISO 13485 Microbiology Pharma Analytical Stability studies GMP Raw material HPLC Testing

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are seeking a Quality Control (QC) Manager to oversee product testing, quality analysis, and
compliance with regulatory standards. The QC Manager will be responsible for ensuring the integrity of raw materials, in-process materials, and finished products.

Designation:

QC Manager

Department:

Quality Control

Experience:

Minimum 7 years in Medical Device/Pharma/Life Sciences Industry

Regulatory Experience:

Minimum 3-5 years in GMP, US FDA, ISO 13485, and Analytical Testing

Industry/Background:

Medical Device / Pharma / Lifesciences Industry

Qualification:

B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field

Employment Status:

Permanent

Workplace Type:

On-site

Minimum Requirements:

Strong knowledge of analytical techniques, stability studies, and microbiology testing.
Experience in handling QC documentation, test reports, and specifications.
Proficiency in GMP, ISO 13485, US FDA, and MDSAP compliance.
Expertise in using HPLC, GC, UV, and other analytical instruments.
Experience in raw material, in-process, and finished product testing.
Strong knowledge of deviation handling, OOS investigations, and CAPA.
Ability to lead a QC laboratory and ensure smooth functioning of testing operations.

Roles and Responsibilities:

Oversee quality control operations and ensure compliance with regulatory standards.
Ensure proper testing and validation of raw materials, in-process, and finished products.
Review and approve test reports, analytical data, and quality records.
Monitor and maintain stability studies and analytical testing procedures.
Conduct investigations for out-of-specification (OOS) results and deviations.
Ensure the calibration and maintenance of laboratory instruments.
Coordinate with cross-functional teams to ensure product quality.
Support regulatory submissions and participate in regulatory inspections.

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