Specialist* QA Operations
Open for hire at one of the following locations – Singapore. - Job ID: 6325
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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 Operations
As Specialist* QA Operations you are responsible to help ensure that operations are in alignment and compliant with global Quality, internal and general GxP requirements. You ensure that raw materials are tested meeting specifications and DS, DP are produced meeting the specifications per the dossier and approved appropriately for release.
Your main responsibilities are:
- Execute the assigned Quality Process according to established procedures and requirements
- Help to establish, support and ensure GMP compliance in operations
- Provide general operations (Batch Records, SOP, Deviations, Change Controls etc) and disposition support
- Report and present assigned Quality Process metrics
- 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
- Participate in cross-functional collaboration for execution of the assigned Quality Process
- Support regulatory inspections and audits
- Adherence to safety requirements
- Report any condition impacting quality and compliance to Quality Assurance Management
- Participate in projects and improvement initiatives
What you have to offer:
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Advanced Degree/Degree, Diploma in Science, Pharmacy, Pharmaceutical Science, Engineering
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Preferably 3-5 years professional experience in Pharmaceutical in the field of Quality Assurance or Operation
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Hands on experience on validation/ qualification of manufacturing equipment’s/systems etc. is a plus
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Working knowledge on various validation regulatory guidelines such as FDA/EU cGMP, PDA Technical guide, GAMP requirements etc.
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Knowledge on Data Integrity and Compliance with cGMP
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Knowledge in Quality Assurance concepts
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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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