SME Corporate Validation

Title

SME Corporate Validation

Location:

Mumbai/Baroda

Key Responsibilities

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 Description

• Establish Qualification approach for complex equipment and process. Ensure establishment of Global Qualification standard for equipment/system in SUN formulation site (Drug Product).
• Establish Global SOP for various system to optimize the validation practices, usage and cost implicated on qualification.
• Establish Qualification strategy for Greenfield and Brownfield projects.
• Resolve issue escalated from sites pertaining to equipment qualification, GMP process and sterility assurance.
• Establish Qualification strategy for Process control system.
• GMP Audit support with respect to Audit readiness, Response.
• Develop capability of Equipment qualification team.
• Mentor Qualification leads and SMEs across regions.
• To centrally organize, guide, control the qualification and validation programmed of each site.
• Plan for improvement in line with best industrial, cGMP and regulatory requirement.
• Support the site team in evaluating the skid design.
• Identify the training needs of Qualification personnel across the sites. Training of Qualification team on latest trends in Qualification of Clean utilities, Facility, Equipment
• Review of Qualification related to GSOP/s & GQS.
• To identify the lapses and possible improvement in the system in line with regulatory and industrial practices.
• Coordinating the sites for effective completion of qualification activity within stipulated timelines.
• Guidance & Trouble shooting during Qualification activity.
• To identify the new software for Qualification activity.
• Standardization of Equipment URS. Harmonization of Qualification Protocol, Report template & Formats.
  
  

Travel Estimate

50-60 %

Job Requirements

Educational Qualification

Graduate (Science and Engineering)

Experience

18 Years+ in Pharmaceutical Validation/Operation /Engineering /Compliance.

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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