Annual Product Quality Release Specialist

hace 5 días

Ciudad de México Novartis A tiempo completo

391532BR

**Annual Product Quality Release Specialist**:
Mexico

**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

**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 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

**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

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