Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role.
Post : Specialist - Quality Operations (GQS I)
Job Description
• Extract data from relevant sources in Sandoz tools/ applications.
• Interpret and compile external supplier APQR and/ or extracted data from Internal Sandoz systems into a pre-defined template and draft conclusion of product quality review.
• Collect contributory reports for product related evaluations.
• Interact with CMOs and / or manufacturing sites as required.
• Support in updating and maintenance of APQR schedule.
• Author/review/approval of APQR report/ data as applicable to ensure it is complete and correct.
• Complete APQRs within defined timelines.
• Archive the approved APQR as applicable.
• Initiation of Shopping Carts for procuring Documents from Suppliers as required.
• Preparation, Review of Analytical Comparison report as per the EU requirement or any other contributory reports for APQR as applicable.
• Support/execute/involve in QMS activities but not limited to self-inspection, D2 ESOPs, Investigation, QARP, FURP etc. as required by eligible/applicable associates.
Candidate Profile
• Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute.
• Fluent in English (written and spoken)
• Good communication, presentation, and interpersonal skills
• Minimum 3 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
• GxP knowledge, Basic IT knowledge
• Experience of working closely with the global stakeholders
Additional Information
Experience : Minimum 3 years
Qualification : Pharmacy/ Science/ MBA
Location : Telangana (Sandoz)
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th January 2025
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