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.
