Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
3 Years
Description
- Reviewing and approving Process Validation / Equipment Validation documents promptly, including Microbial Mapping validation protocols, resin re-use protocols, cleaning validation protocols, new equipment, etc.
- Active participant in deviation investigations.
- QA Approval of quality records including but not limited to; Deviations, CAPAs, Audit findings etc.
- Reviewing and endorsing QA controlled documents within the Quality Management System.
- Supports compliance to systems timeframes for raising, processing or performing associated tasks (i.e. Change Control actions, DR investigations, processing CAPAs).
- Issuing protocols as required to other departments.
- Updating SOPs and other documents to meet current regulatory and corporate standards.
- Serving as a resource to the operational areas on quality-related issues.
- Identification of continual improvement opportunities.
- Participating in Risk Assessments.
- Any other legitimate duties requested by QA Manager.
Qualifications
Highest qualification: University
- Tertiary Academic level in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).
- At least 3 years of experience in a GMP regulated setting.
- Ideally, at least 1 year of experience in Quality Assurance within a GMP-regulated setting is preferred.
Skills & Attributes
- Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
- Strong communication skills.
- Strong written, verbal and presentation skills.