QC Manager

3 weeks ago

Salem, India Cologenesis Healthcare Pvt Ltd Full time

Key Responsibilities:

· Lead and manage QC operations for raw materials, in-process, and finished products.

· Oversee analytical testing methods: HPLC, UV Spectrophotometer, Kjeldahl, KF Titrator, SDS-PAGE, Hydroxyproline test, Protein content analysis.

· Review and approve COAs, protocols, and reports in compliance with GMP, ISO 13485, and 21 CFR Part 11.

· Ensure calibration and preventive maintenance of QC instruments.

· Train and mentor QC team to maintain accuracy, compliance, and data integrity.

· Handle deviations, OOS/OOT investigations, and implement CAPA.

· Ensure audit readiness and regulatory compliance at all times.

· Prepare, review, and control QC documents (SOPs, protocols, reports, records).

· Approve test protocols and reports; ensure proper record keeping.

· Plan and utilize manpower, equipment, and consumables effectively.

· Oversee method validation, verification, and transfer for chemical and microbiological tests.

Qualifications & Experience:

· M.Sc. (Chemistry / Biochemistry) or B.Pharm / M.Pharm.

· 5-8 years of QC experience in pharmaceuticals / medical devices / biotech,

· Strong knowledge of analytical techniques and regulatory requirements.

· Experience in handling customer and regulatory audits preferred.

Job Type: Full-time

Pay: From ₹35,000.00 per month

Benefits:

  • Paid sick time
  • Paid time off

Experience:

  • hr: 2 years (Preferred)
  • HR sourcing: 1 year (Required)

Language:

  • English (Required)

Work Location: In person

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