Title:  Deputy General Manager - Sterility Assurance

Job Title:

DGM – Sterility Assurance

Business Unit:

Global Quality & Compliance

Job Grade

G8

Location :

Baska

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.”

Job Summary: 

In this Job role we are looking for Sterility Assurance, QMS elements for Sterile manufacturing Units with experience in Regulatory Audit Queries.

Key responsibilities:

• Owning of Aseptic process simulation program of the site including protocol / operators and intervention qualification program / Trending and Aseptic process simulation summary report.
• Own and continually develop the Site’s Contamination Control Strategy.
• Ensure Contamination control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Lead Sterility Assurance committee for the site .
• Review and approval of Microbiological environmental monitoring program, identify trends and implement effective risk mitigation
• Guide the investigation of contamination – related non-conformance and events and provide technical input for microbiological method transfers.
• Serve as subject matter expert on sterility assurance during regulatory inspections, audits and cross functional initiatives.
• Support inspection preparation and execution during health authority on-site inspection as an expert in Sterility Assurance
• Assess differences in current sterility assurance programs across the sites and drive harmonization
• Provide mentoring leadership to site SMEs to help build continue to build capability on Sterility assurance program, where deep technical expertise is lacking
• Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the network.
• Maintain compliance with governing regulations and lead by example in promoting best contamination control practices through ongoing training and floor presence
• Collaborate with operations and QC micro lab to design and deliver robust training programs on aseptic processing, aseptic behavior and principles for site staff.
• acting as the site's subject matter expert during audits
• Identify opportunities for process improvement in aseptic techniques.
• The lead mentors and develops junior sterility assurance staff and site SMEs to build technical expertise within the organization
• Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc  - Microbiology

Experience

Tenure:  15+ Years (with Sterile / Regulatory Plants)

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).