Job Description

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

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate\'s qualifications and experience.

How to apply:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it\'s a match!

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