Site Quality Head (Karnataka)

Site Quality Head (Karnataka)

08 Aug
|
Merck
|
Karnataka

08 Aug

Merck

Karnataka

Work Your Magic with us Ready to explore break barriers and discover more We know you ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people s lives with our solutions in Healthcare Life Science and Electronics Together we dream big and are passionate about caring for our rich mix of people customers patients and planet That s why we are always looking for curious minds that see themselves imagining the unimaginable with us 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 Lead and manage the Quality Assurance and Quality Control teams ensuring effective implementation of quality systems and processes Develop implement and maintain quality policies and procedures in compliance with cGMP and regulatory standards Monitor and ensure adherence to quality standards throughout the manufacturing process from raw material receipt to finished product release Conduct regular audits and inspections of manufacturing processes facilities and systems to ensure compliance with cGMP regulations Collaborate with cross-functional teams including Manufacturing Regulatory Affairs and Research Development to address quality issues and drive continuous improvement initiatives Manage investigations and root cause analyses for deviations non-conformances and complaints implementing corrective and preventive actions as necessary Prepare and present quality metrics and reports to senior management ensuring transparency and accountability in quality performance Stay updated on industry trends and regulatory changes ensuring the site s quality systems remain compliant and effective In-depth knowledge of cGMP regulations and quality management systems Strong analytical and problem-solving skills with a proactive approach to quality management Excellent communication and interpersonal skills with the ability to influence and collaborate across all levels of the organization Proven track record of leading quality improvement initiatives and driving compliance in a manufacturing environment Proven track record of managing technology transfers including customer notification change control qualification validation regulatory compliance Who You Are Bachelor of Engineering in Mechanical Electrical Chemical Biotechnology Masters in Microbiology Must have around 20 years experience in Quality and at least 3 years worked as head of site quality Worked in reputed Pharmaceutical Manufacturing - Industry preferably positive MNC s cGMP as per FDA EU GMP ICH ISPE PICs DOE SQC Good understanding on tools like FMEA Change Control Stability Study Qualification and Validation Cleanroom requirement Environmental monitoring Stability studies AHU Customer focused strong communication skills Proactive and decisive personality Team player What we offer We are curious minds that come from a broad range of backgrounds perspectives and life experiences We believe that this variety drives excellence and innovation strengthening our ability to lead in science and technology We are committed to creating access and opportunities for all to develop and grow at your own pace Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

📌 Site Quality Head (Karnataka)
🏢 Merck
📍 Karnataka

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