Role Overview
Develop, support and drive excellence in MCOQ GMP&GDP Quality activities to maintain the local License to Operate, define and monitor quality policies, ensure QMS compliance, and lead continuous improvement in the region.
About Astrazeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world's most serious diseases.
Key Responsibilities
- Develop, support and drive excellence in MCOQ GMP&GDP Quality activities to maintain the local License to Operate
- Participates in defining the strategy for the commercial global markets ownership and execution of MCOQ GMP and GDP Quality System and framework in country
- Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in country markets
- Supports local MC to deliver the license to operate, including but not limited to support for GMP&GDP/GSP audits and inspections
- Responsible for ensuring QMS compliance and continuous improvement in the Region and all issues are managed and closed on time
- Represent Quality on cross-functional and cross SET teams and steering committees related to MC market
- Drive global standardisation, simplification, and improvement of MCOQ Quality business processes
Requirements & Eligibility
- Licensed Pharmacist is mandated
- Degree or equivalent professional qualification in related field
- 8+ years’ experience in quality assurance within a GMP/GDP/GSP environment
Required Skills & Tech
Quality AssuranceGMPGDPGSPQuality Management SystemCompliance