QC Manager

We are looking for a QC Manager for a leading Global Pharmaceutical MNC based in Bangalore.

Position: QC Manager (OSD Formulation)

Experience: 15+ years in QC

Qualification: Masters in Chemistry/ LifeScience

Location: Bangalore

As the Quality Control Manager, you will play a pivotal role in overseeing analytical activities, instrument calibration/qualification, investigations, and documentation within the Quality Control department. Your responsibilities will encompass ensuring adherence to established procedures, coordinating with various stakeholders, and maintaining compliance with regulatory standards.

Responsibilities:

1. Report to the Head of Quality & Compliance and provide updates on day-to-day activities in the Quality Control department.
2. Ensure that operations in the Quality Control Laboratory comply with established standard procedures.
3. Identify training needs for departmental employees and facilitate their fulfillment.
4. Provide support to Manufacturing Operations during the execution of exhibit batches/commercial batches within specified timelines.
5. Assess, review, approve, and ensure timely completion of changes in the QC department as per approved change control procedures.
6. Ensure timely completion of analysis of commercial samples.
7. Coordinate with service engineers to ensure smooth functioning of all laboratory instruments.
8. Review and approve SOPs and testing directions for laboratory samples in QC.
9. Perform all work in accordance with established regulatory, compliance, and safety requirements.
10. Conduct investigations for out-of-specification/out-of-trend results and ensure timely completion of analytical investigations.
11. Evaluate Investigation, Deviations, CAPA, and Change Control Records and provide managerial approval.
12. Maintain a disciplined work environment and provide expertise to subordinates/colleagues in laboratory procedures.
13. Interact with QA department/auditors during inspections or audits conducted by regulatory authorities.
14. Assist Quality group in various activities such as data compilation for Annual Product Quality Review (APQR), Training, Vendor development programs, Self-inspection, and External audit programs.
15. Participate in handling market complaints/product recalls/quality-related returns in coordination with the Quality group.
16. Stay updated with latest cGMP/GLP/regulatory requirements and train departmental personnel accordingly.
17. Conduct performance conversations with employees and reinforce performance expectations to encourage a high-performance culture and safe working environment.
18. Build trust-based relationships with employees, business partners, and leaders while continuously improving leadership capabilities.
19. Foster a culture of trust and provide opportunities for employee development and growth.
20. Utilize networks to attract and hire talent and ensure a consistent onboarding experience.
21. Ensure adherence of team members with all compliance programs and company policies and procedures.
22. Undertake any other assigned tasks by seniors.

Requirements:

• Education: Minimum MSc/B Pharma or equivalent degree.
• Skills: Effective communication, proficiency in MS Office tools, knowledge of document preparation and review, troubleshooting skills, familiarity with regulatory guidelines and cGMP activities, ability to prioritize tasks.
• Experience: Minimum 16 to 20+ years of experience in GMP regulated Pharmaceutical industry.

Interested candidates can share their resume at [Confidential Information]