Annual Product Quality Release Specialist (Xico)

Annual Product Quality Release Specialist

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.

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 SOPs.
• 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 record‑keeping 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.

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.

Role Requirements

• Functional Breadth: English
• Knowledge of compliance requirements 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

Job Details

• Division: Operations
• Business Unit: QUALITY
• Work Location: Ciudad de México
• Company/Legal Entity: NOV CORPORATIVO MEX
• Functional Area: Quality
• Job Type: Full Time
• Employment Type: Regular
• Shift Work: No
• Early Talent: Yes