Sr eCompliance Specialist
Sandoz India Pvt Ltd
အလုပ်တည်နေရာ
Madhavaram, Telangana
အလုပ်ခန့်သည့်ပုံစံ
အချိန်ပြည့်
အလုပ်ခေါ်စာအသေးစိတ်
Job Description
Your Key Responsibilities:
• Oversee the quality of project and operational activities for GxP systems, including changes, periodic reviews, deviations, and other related processes. Support the compliance of GxP-regulated computerized systems projects with all relevant Sandoz policies and regulatory requirements.
• Serve as the primary contact for all CSV-related matters pertaining to GxP computerized systems, acting as a liaison between IT and Business to promote a Quality Culture for eCompliance.
• Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. Build trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support.
• Review and approve the GxP Changes and the associated deliverables. In addition, review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.
• Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions. Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System.
• Review and approve the Infrastructure Qualification Project Deliverables, Infrastructure Operational Changes and the associated deliverables.
• Conduct supplier qualification assessment activities. Provides audit support as assigned and in case of CAPAs, provides the required Quality support.
Essential Requirements
What you’ll bring to the role:
• Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent
• 5-8 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance
You’ll Receive
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
#Sandoz
