Manager QMS

13 hours ago

Halol, India SUN PHARMA Full time

Job Title: Manager-1 Business Unit: Halol Non sterile - QMS Job Grade G10 Location : Halol At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Act as Site Coordinator with strong understanding of track-wise functionality to ensure smooth operations. Facilitate and moderate critical meetings such as Monthly Quality Review Boards, CAPA Review Boards, and Change Control Review Boards with effective communication and technical expertise. Review and approve Standard Operating Procedures (SOPs), investigations, extensions, and Quality Management System (QMS) records. Design, implement, and maintain compliance with quality-related SOPs, policies, and QA systems, including Site Master File, Quality Manual, CAPA, Change Control, Management Review, Annual Product Review (APR), Continued Process Verification (CPV), Complaint Handling, Field Alert Reports (FAR), Recall, and Quality Alerts. Conduct training programs for QA officers, executives, technicians, and contract staff to ensure adherence to quality standards. Provide proactive leadership and foster collaboration across cross-functional teams. Plan and coordinate internal and external QA support activities. Manage Annual Product Review (APR) and Product Quality Review (PQR) processes. Oversee Continued Process Verification (CPV) protocols, data trending, and reporting. Handle Product Quality Complaints (PQC), FAR, Recalls, and Quality Alerts effectively. Prepare and present Quality Metrics and Quality Review Board (QRB) reports. Travel Estimate Nil Job Requirements Educational Qualification Post graduate in science/pharmacy Experience Tenure: 12 to 13 years Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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