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Job Opportunity

Job Opportunity
QA Operation Specialist
Aug. 10, 2021
QA Operation Specialist
Germany Wuppertal
Wuppertal
major responsibilities:

Reporting to the QA Drug Substance Group Lead, this role will provide online QA oversight to Drug Substance manufacturing operations. This is a crucial role within

the Quality organization with responsibility for directly supporting the manufacturing operations team on a daily basis, ensuring compliance with cGMP and corporate and

local SOPs.

 

Essential Duties and Responsibilities

  •   Providing QA support to technology transfer and commercial manufacturing operations.
  •   Perform QA review of SOPs, risk assessments, change controls and otherdocumentation, as applicable, associated with Drug Substance manufacturing operations
  •   Ensure that Drug Substance manufacturing operations are conducted according to appropriate   behaviors 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.
  •   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.

 

qualifications requirements:

 

Requirements 

 

  •   A Bachelor’s degree in a technical discipline (e.g., biochemistry, chemistry, engineering) would be an advantage. 
  •   Experience in the biotechnology and/or pharmaceutical industry within a Quality operations role
  •   Experience in qualification / validation is highly desired
  •   Strong aptitude with ability to interpret technical documentation 
  •   Strong knowledge of cGxP requirements and regulations, Experience in performing internal audits is ideal 
  •   Excellent language skills in English and preferably German (written and oral)
  •   Willingness to work shifts

 

 

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

Then please click the “Apply now” button.

We look forward to receiving your application documents, stating your salary expectations and the earliest possible starting date.

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