Title:  Manager - Quality Assurance

Job Title:

Manager Quality Assurance

Business Unit:

Global Quality & Compliance

Job Grade

G10

Location :

Mohali

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:

• Responsible for monitoring of all cGMP activities at site.
• Facilitate review and support regulatory inspection management.
• Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal\customer audits.
• Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
• Collaborate with Corporate compliance group and implement global CAPA.
• Facilitate, review and monitor cross functional investigation teams.
• Support plant for management of compliance activities.
• Regularly evaluate and report compliance status of site to Site Quality Head.
• Support for major health authority inspections at site and provide input and support to inspection responses to drive consistency and clarity at the site.
• Support compliance investigations as needed in collaboration with others at the site.
• Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.
• Provide support in execution and monitoring of remediation compliance through compliance verification audits.
• Responsible for all compliance and bringing solutions to compliance related issues within the site.
• Review Regulatory inspection observations, trend and decide compliance strategy.
• Educate and institutionalize a culture of Quality and compliance at the site.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Provide appropriate training and development to support staff to meet their respective job responsibility.
• To perform Gap Assessment for assessment of internal and external corporate compliance report for all 483's & warning letters against the site and to ensure compliance as per SOP.
• To perform self-inspection (Internal Audits) for all quality systems & sub systems at the site.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure:  13 to 15 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).