Specialist* QA Systems

Open for hire at one of the following locations –  Singapore. - Job ID: 6324 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
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 Systems 

Your main responsibilities are: 
 

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

• Administer and maintain the electronic system and contingency plan for Documentation, Training and Knowledge Management 

• Administer the archival system and maintain the archival room for GMP documents according to site retention requirements 

• Administer and maintain the electronic system and contingency plan for Change Control and Deviation/CAPA 

• Report and present assigned Quality Process metrics 

• Chair the relevant forums of assigned Quality Process 

• Support or conduct training for the assigned Quality 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 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 2-5 years of relevant working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry 
• Knowledge in Quality Assurance concepts 
• Good communication skills