External/Internal GMP Inspection

-Prepare annual plant internal audit plan 

-Maintain internal &external audit system and ensure its implementation

- Carry out internal audit

- Prepare training plan of internal auditor and manage internal auditor certification process

- Coordinate external GMP inspections

- Coordinate CAPA creation,  review and  follow-up CAPA implementation Compliance affairs 

Compliance affairs 

-Prepare and submit the documents for GMP certification and filing etc.

-Maintain GMP relevant license and ensure validity.

-Document and data preparation and submission to authorities

-Support regulatory affairs, and coordinate and carry out the review of registration dossier within Taizhou site

-Keep good communication with authorities

Change management

- Establish and maintain change  management system based on GMP and QCM requirements

- Coordinate, coach and supervise effective execution of change control

- Review and approve global and local changes

- Organize change review meeting to ensure all changes are reviewed effectively

- Provide effective training and support to change users

GMP requirements

- Establish and maintain quality management system based on GMP requirements

- Supervise effective execution of GMP

- Provide GMP support, suggestion and training to other functions  Regulatory Compliance

- Focus on changes of regulations and impact assessment, and communicate with other functions

- Ensure regulatory compliance of quality management system

Supervisory responsibilities

-Assist the team leader to manage daily job in compliance department

-Assist the team leader to build and develop team capability

Quality Management System Business

- Ensure that the CIP is generated, maintained and regularly reviewed.

- Ensure that the Quality Management Review meeting is organized, actions are tracked and keep continuous improvements.

SHE responsibilities

Requirements

University graduate or above 

Good GMP and quality system management knowledge.

Ten years plus experience in the Pharmaceutical Industry, with at least seven years’ experience in QA. 

Multiple site or function experience

Good English

Date Posted

20-5月-2021

Closing Date

30-8月-2021

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.