Specialist* QA Compliance

Open for hire at one of the following locations –  Singapore. - Job ID: 6326 

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We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Specialist* QA Compliance 

As a Specialist* QA Compliance you are responsible for internal audits, external audits and regulatory inspection management and support Quality processes. You act as a check and balance for internal operations, help ensure alignment to global quality, internal and general GxP requirements for vendor and material management. 

Your main responsibilities are: 

• Execute the assigned Quality Process according to established procedures and requirements 

• Provide QA support for internal and external audit and inspection management 

• Provide QA support for vendor and material management 

• Provide QA support for Quality Risk Management, Quality Management Reviews and APQR 

• Report and present assigned Quality Process metrics 

• Chair the relevant forums of assigned Quality Process 

• Support or conduct training for the assigned process as appropriate 

• Serve as backup for other assigned Quality Process as appropriate 

• Complie with applicable current GMP and regulations to execute assigned tasks 

• Follow established procedures and requirements to execute assigned tasks 

• Adhere to data integrity requirements for paper and electronic documentation 

• Complete training requirements before performing assigned tasks 

• Support execution for the procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process 

• Participate in cross-functional collaboration for execution of the assigned Quality Process  

• Support the coordination and preparation of regulatory inspections and audits  

• Report any condition impacting quality and compliance to Quality Assurance Management

• Participate in projects and improvement initiatives

What you have to offer: 

• Advanced Degree/Degree, Diploma in Science, Pharmacy, Pharmaceutical Science, Engineering

• Preferably 3-5 years of relevant working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry 

• Knowledge in Quality Assurance concepts 

• Good communication skills