职位信息

招贤纳士

职位信息

Floor QA Specialist

立即申请

May. 05, 2021

Floor QA Specialist

中国

Standort Wuppertal

工作职责：

Providing QA support to technology transfer and commercial manufacturing operations.
Perform QA review of SOPs, risk assessments, change controls and other documentation, as applicable, associated with Drug Substance manufacturing operations
Ensure that Drug Substance manufacturing operations are conducted according to appropriate cGMP behaviours and in compliance with SOPs, batch manufacturing records and other cGMP documentation as applicable.
Liaise with Manufacturing Operations to ensure that all deviations, investigations and batch manufacturing record reviews are performed, addressed and closed out in a timely manner as defined in SOPs.
Work with Manufacturing Operations to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to manufacturing operations are addressed and closed out in the required time frame.
Liaise with manufacturing operations, QA, QC, Engineering, MSAT etc. in supporting daily operations.
Ensure clear communication on issues and timely escalation as applicable.
Identify opportunities for continuous improvement.
Support internal Quality peers to ensure on-time disposition of drug substance material.
Provide support for the preparation of regulatory submissions and inspection readiness activities.
Perform onsite quality monitoring of GMP areas.
Provide support for health authority inspections including responses to inspection observations, and monitoring of follow up actions.
Perform additional duties at the request of direct supervisor.

任职能力：

Technical Competencies

Strong aptitude with ability to interpret technical documentation
Strong knowledge of cGxP requirements and regulations
Knowledge of trouble shooting and problem solving skills; e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc
Demonstrated knowledge of Quality Management System and continuous/process improvement tools

Experience

Experience in the biotechnology and/or pharmaceutical industry within a Quality operations role preferred
Candidates from Manufacturing Operations, Validation, Engineering and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered but demonstrated experience in Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required
Experience in performing internal audits is ideal
Experience in supporting Technology Transfer projects would be an advantage

Knowledge

Demonstrated knowledge of Quality Management System and continuous/process improvement tools

Qualifications

A Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering) would be an advantage

Behavioural Competencies

Adaptable, able to multi-task and handle tasks with competing priorities effectively to deliver site priorities
Demonstrated organisation and collaboration skills with a teamwork mind-set
Excellent communication skills (written and oral)
Analytical with demonstrated problem solving & root-cause analysis skills
Proactive attitude with good attention to detail

Other considerations

This position will work closely with manufacturing business and therefore shift work will be part of this role

其他要求:

Are you interested in becoming part of this culture and actively shaping the future of WuXi Biologics?

Then we look forward to receiving your application documents (CV in German and English), stating your salary expectations and the earliest possible starting date.

Please send your application by e-mail to: Recruiting_Germany@wuxibiologics.com

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