Technical Expert QA (Systems)
Open for hire at one of the following locations – Singapore. - Job ID: 7198
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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.
Technical Expert QA (Systems)
As Technical Expert for QA Systems, you are responsible to lead, establish, support and and be the Subject Matter Expert for the assigned quality process. You are responsible to administers and maintains the electronic system and contingency plan for Change Control, Deviation, CAPA and Effectiveness Check 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:
- Administers and maintains the electronic system and contingency plan for Change Control, Deviation, CAPA and Effectiveness Check
- Reports and presents assigned Quality Process metrics
- Chairs the relevant forums of assigned Quality Process
- Serves as site representative in network calls and multi-site change controls
- Lead/participates in root cause analyses and investigations
- Approves/assesses QA system-related change controls
- Approves/initiates QA system-related deviations/CAPAs
- Supports or conducts training for the assigned process as appropriate
- Serves as backup for other assigned Quality Process as appropriate
- Complies with applicable current GMP and regulations to execute assigned tasks
- Completes training requirements before performing assigned tasks
- Supports execution for the procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
- Participates in cross-functional collaboration for execution of the assigned Quality Process
- Supports regulatory inspections and audits
- Reports any condition impacting quality and compliance to Quality Assurance Management.
- Participates 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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Preferably10 years in Pharmaceutical in the field of Quality Management system in the pharmaceutical/biotechnology/medical device industry
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Deep knowledge on various validation regulatory guidelines such as FDA/EU cGMP, PDA Technical guide, GAMP requirements etc.
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Expert knowledge on Data Integrity and Compliance with cGMP
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Deep 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
- 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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