Annual Product Quality Release Specialist

About the role

Location:#LI#CDMX#Hybrid About the role:
We are looking for a specialist in APQR whose activities will impact in getting products to the market with the highest quality to positively impact people's lives through innovative, life-changing therapies. Main Responsibilities: •Responsible for the preparation of the Annual Product Quality Review (APR/PQR) Report for Sandoz marketed products and selected third party products in accordance with company and regulatory requirements.
•Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data (HA commitments, variation.
•Responsible for the preparation, review and approval of the APR/PQR Report according to the established schedule.
•Responsible for collecting stability data and reports for product related evaluations. (e.g. compliance investigations, divestitures, product transfers, validation. etc.)
•Responsible for writing and updating applicable SOP's.
•Support maintenance of APR/PQR schedule. Responsible for scheduling meetings with the APR Team to resolve and assign follow-up action items, if required.
•Responsible for the APR/PQR Report recordkeeping progress and flag any delays on time. Support QA Manager responsible for the review of the APR/PQR and stability reports to ensure compliance with Sandoz requirements.
•Communicate with internal partners and Business Partners as required

Role Requirements

•Functional Breadth English
• Knowledge of compliance requirement for all internal and external regulations
•Knowledge of TQM and related industry GxP standards and processes Quality Standards.
•3 years of experience in similar roles

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.