Sr. Manager - Quality Control

BDR Pharmaceuticals

10 - 15 years

10 - 15 Lacs

vadodara

Posted:23 hours ago| Platform:

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Skills Required

quality control uv qc oos coa oot sop qms quality management gmp gc hplc

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Oversee daily QC operations including sampling, testing, and release of materials and products.
Ensure compliance with GMP, GLP, and regulatory guidelines (e.g., USFDA, WHO, EU).
Review and approve analytical reports, COAs, SOPs, and method validations.
Manage QC documentation and data integrity in line with regulatory expectations.
Lead investigations for OOS/OOT results and implement effective CAPAs.
Coordinate with cross-functional teams (QA, Production, RA, R&D) for timely product release and regulatory submissions.
Monitor and maintain calibration and qualification of laboratory instruments (HPLC, GC, UV, etc.).
Supervise stability studies and ensure timely analysis and reporting.
Prepare for and support internal and external audits, including regulatory inspections.
Mentor and train QC staff, fostering a culture of quality and continuous improvement.

Additional Requirements

Experience in handling regulatory audits (USFDA, MHRA, WHO, etc.).
Familiarity with CTD/eCTD dossier requirements for QC sections.
Ability to manage multiple projects and meet tight deadlines.
Strong focus on safety, compliance, and team development.

Position details:

Sr. Manager - Quality Control
Location - Vadodara (Baska)
Required Exp. - 12 - 15 years

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