Quality Control Manager

12 hours ago


Pune, Maharashtra, India Sokariba International Ventures Full time

Job Title: Quality Control Manager Pharma

Industry: Pharmaceuticals

Functional Area: Quality Control

Role Category: Quality Control Manager

Job Location: Sterling Healthcare Ltd., Talegaon, Pune

Employment Type: Full-Time

Experience Required: 5– 10 Years

Job Description

Sterling Healthcare Ltd. is seeking an experienced Quality Control Manager to lead and manage Quality Control laboratory operations in a pharmaceutical manufacturing environment. The role is responsible for ensuring product quality, regulatory compliance, and adherence to GMP and global quality standards.

Key Responsibilities

  1. Manage and oversee day-to-day operations of the Quality Control laboratory
  2. Ensure testing of raw materials, packaging materials, in-process samples, finished products, and stability samples as per approved specifications
  3. Review and approve analytical test results, Certificates of Analysis (COA), SOPs, protocols, and analytical reports
  4. Ensure compliance with cGMP, GLP, WHO, FDA, ICH guidelines, and pharmacopeial standards (USP, EP, IP, BP)
  5. Investigate and manage OOS, OOT, deviations, change controls, and CAPA
  6. Support and participate in regulatory inspections, customer audits, and internal audits
  7. Oversee analytical method validation, verification, and method transfer activities
  8. Ensure calibration, qualification, and preventive maintenance of laboratory instruments
  9. Monitor and manage stability studies in compliance with regulatory requirements
  10. Lead, train, mentor, and develop Quality Control team members
  11. Ensure data integrity (ALCOA+) and adherence to proper documentation practices

Key Skills & Competencies

  • Pharmaceutical Quality Control
  • GMP / GLP Compliance
  • Analytical Techniques: HPLC, GC, UV, IR, Dissolution
  • OOS / OOT / Deviation / CAPA Handling
  • Analytical Method Validation & Transfer
  • Stability Studies
  • Regulatory Audits (FDA / WHO)
  • Team Management & Leadership

Education & Qualification

  • M.Pharm / MSc (Chemistry / Analytical Chemistry)

Experience

  • 5–10 years of experience in Pharmaceutical Quality Control
  • Minimum 3–5 years in a managerial or supervisory role
  • Prior experience handling regulatory inspections is preferredRole & responsibilities

Preferred candidate profile



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