Associate Director Clinical QA Compliance ensuring quality and integrity of clinical development activities at BioNTech. Leading the proactive, risk - based Quality Strategy implementation across clinical trials.
About the role
- Officer Quality Assurance managing various Quality Assurance documents at Orion Pharma. Preparing and reviewing documents related to Quality Assurance processes with a focus on Pharmaceuticals.
Responsibilities
- Preparation and Review of Certificate of Analysis (CoA)
- Analytical Result entries to SAP batch data
- Maintenance of SOPs and Internal guidelines in SAP
- Handling of Computerized Training Management system related activities
- Handling of GMP/ MIA certificate availability activity
- Handling of Change Request Forms through Computerized software
- Managing various Quality Assurance documents and notifications
- Preparation of Report for QA activities
Requirements
- 2 - 4 years’ experience in Quality Assurance (preferably Pharmaceuticals)
- Experience in managing various Quality Assurance documents and notifications
- Proficient in MS Office
- Experience of working in ERP / SAP and computerized systems would be an added advantage
- Good English communication skills (both verbal & written)
- Good Interpersonal Skills
- Ability to work in team and flexibility to adapt to change
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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