Technical Expert QA (Systems)
BioNTech
- Singapore
- Permanent
- Full-time
- 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
- 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