Technical QA Expert*

Open for hire at one of the following locations –  Singapore. - Job ID: 6323 

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.

Technical QA Expert* 

As Technical QA Expert* you are responsible to lead, establish, support and help ensure that Commissioning, Qualification and Validation for Facilities, Utilities and Equipment, Computerized Systems, process, analytical and microbiology methods etc in operation areas in BioNTech SGP is in alignment and compliant with global Quality, internal (Site VMP) and general GxP requirements.

Your main responsibilities are:

• Leads, creates, executes the assigned Quality Process according to established procedures and requirements 

• Function as the Quality subject matter expert and responsible to review and approve validation protocols, reports, risk assessment and other validation related documents for equipment’s, computerized systems, HVAC & utility systems, process validation, Analytical & Microbiology methods etc.   

• To ensure validation documents are compliance with internal procedure or regulatory requirements

• Responsible to review and approve specification documents in compliance with validation requirements.

• Support the review of the validation related standard procedures

• Quality oversight for validation maintenance program

• Reports and presents assigned Quality Process metrics 

• Supports or conducts training for the assigned Quality Process as appropriate 

• Serves as backup for other assigned Quality Process as appropriate 

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

• Follows established procedures and requirements to execute assigned tasks 

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

• Supports regulatory inspections and audits  

• Adherence to safety requirements  

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

• Participates in projects and improvement initiatives 

What you have to offer: 

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

• Preferably 8-10 years in Pharmaceutical in the field of Quality Assurance or Validation

• Hands on experience on validation/ qualification of manufacturing equipment’s /systems etc. 

• Deep knowledge on various validation regulatory guidelines such as FDA/EU cGMP, PDA Technical guide, GAMP requirements etc.  

• Expert knowledge on Data Integrity and Compliance with cGMP 

• Deep knowledge in Quality Assurance concepts 

• Good communication skills