Sr. Manager - QC

Quality HR Services

12 - 18 years

20 - 25 Lacs

ahmedabad

Posted:22 hours ago| Platform:

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Skills Required

cgmp glp hplc qc regulatory guidelines method validation chemistry uv capa quality control qc management production documentation auditing pharmacovigilance ich oos oot clinical research quality assurance qms clinical trials gc inspection

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Lead and oversee the entire Quality Control department operations.
Ensure compliance with cGMP, regulatory guidelines, and company quality standards.
Review and approve analytical methods, specifications, and validation protocols.
Supervise raw material, in-process, and finished product testing.
Ensure timely release of batches and materials.
Manage laboratory investigations, OOS, OOT, deviations, and CAPA.
Coordinate with QA, Production, and Regulatory teams for smooth operations.
Handle audits (internal, external, and regulatory) and ensure readiness at all times.
Provide training, mentoring, and performance evaluation of QC staff.
Drive continuous improvement, cost efficiency, and implementation of new technologies in QC.

Required Skills:

Must be excellent in written and spoken English; net savvy and adept at computer skills
Attention for detail
Strong knowledge of QC systems, cGMP, GLP & regulatory guidelines
Expertise in analytical techniques (HPLC, GC, UV, Dissolution, etc.)
Experience in stability studies, method validation & documentation
Handling OOS/OOT, audits & regulatory inspections
Team leadership, coordination & communication skills
Good in communication

Required Qualification

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