QA Officer

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

• 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.