Job Description

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

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 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

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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