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.

What you ll bring to the role:

Minimum Requirements:

Education: Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute.

Languages:

Fluent in English (written and spoken)
Good communication, presentation, and interpersonal skills

Experience:
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

Skills Desired