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 current 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

📌 SME Corporate Validation (Tandalja)
🏢 SUN PHARMA
📍 Tandalja