Site Quality Head

2 days ago

Bengaluru, Karnataka, India The businesses of Merck KGaA, Darmstadt, Germany Full time ₹ 20,00,000 - ₹ 50,00,000 per year

The Manufacturing Site Quality Head plays a pivotal role in shaping the strategic direction of the organization by ensuring that all products meet the highest standards of quality and compliance. This position directly impacts the company's reputation, operational efficiency, and regulatory standing in the highly competitive pharmaceutical industry. By leading the quality assurance and control processes, the head of quality safeguards patient safety and product integrity, which are essential for maintaining trust with stakeholders, including regulatory bodies, healthcare professionals, and consumers. Furthermore, by fostering a culture of continuous improvement and proactive quality management, this role contributes to optimizing manufacturing processes, reducing costs associated with non-compliance, and enhancing overall operational performance, ultimately driving the company's growth and success in the market.

Your Role:

  1. Lead and manage the Quality Assurance and Quality Control teams, ensuring effective implementation of quality systems and processes.
  2. Develop, implement, and maintain quality policies and procedures in compliance with cGMP and regulatory standards.
  3. Monitor and ensure adherence to quality standards throughout the manufacturing process, from raw material receipt to finished product release.
  4. Conduct regular audits and inspections of manufacturing processes, facilities, and systems to ensure compliance with cGMP regulations.
  5. Collaborate with cross-functional teams, including Manufacturing, Regulatory Affairs, and Research & Development, to address quality issues and drive continuous improvement initiatives.
  6. Manage investigations and root cause analyses for deviations, non-conformances, and complaints, implementing corrective and preventive actions as necessary.
  7. Prepare and present quality metrics and reports to senior management, ensuring transparency and accountability in quality performance.
  8. Stay updated on industry trends and regulatory changes, ensuring the site's quality systems remain compliant and effective.
  9. In-depth knowledge of cGMP regulations and quality management systems.
  10. Strong analytical and problem-solving skills, with a proactive approach to quality management.
  11. Excellent communication and interpersonal skills, with the ability to influence and collaborate across all levels of the organization.
  12. Proven track record of leading quality improvement initiatives and driving compliance in a manufacturing environment.
  13. Proven track record of managing technology transfers including customer notification, change control, qualification & validation, & regulatory compliance.

Who You Are:

  1. Bachelor of Engineering in Mechanical /Electrical/Chemical/ Biotechnology/ Masters in Microbiology.
  2. Must have around 20 years' experience in Quality and at least 3 years worked as head of site quality
  3. Worked in reputed Pharmaceutical Manufacturing - Industry preferably good MNC's.
  4. cGMP as per FDA, EU GMP, ICH, ISPE, PICs, DOE, SQC
  5. Good understanding on tools like FMEA, Change Control, Stability Study, Qualification and Validation
  6. Cleanroom requirement, Environmental monitoring, Stability studies, AHU
  7. Customer focused, strong communication skills. Proactive and decisive personality. Team player.

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