About the Position
The brightwater Quality Assurance team is seeking an experienced Quality Assurance Specialist to join our team.
Key Responsibilities
* Co-ordinate Complaints / Quality Defect Reporting Systems, ensuring timely and effective resolution of issues.
* Consult with relevant parties, lead/participate in investigations, agree appropriate Corrective Action Preventative (CAPA) measures.
* Identify and communicate quality issues to leadership that may impact product quality, safety, efficacy, regulatory compliance, or business continuity arising from suppliers or other factors.
* Review/lead Investigations, Root Cause Analysis, and Quality Risk Management exercises to ensure thorough documentation and implementation of CAPA.
* Coordinate local regulatory activities, including update/maintenance of the Site Master File, ensuring compliance with relevant regulations.
* Oversee Supplier Quality Management System, conducting supplier audits, reviewing documentation, generating/reviewing Quality Agreements, coordinating supplier notification system, and conducting periodic reviews.
* Prepare site regulatory audit readiness programs, managing the front room, collating audit responses, agreeing CAPA, etc.
* Support Qualified Person (QP) certification activities, such as batch record review, IMP Order authorization, Product Specification File maintenance, etc.
Experience/Requirements
* Bachelor's degree in a science/quality-based discipline.
* Minimum 10 years' experience in pharmaceutical finished drug product manufacturing environment with working knowledge of EU GMP, US FDA, and other guidelines/regulations.
* Excellent understanding of current/pending EU GMP and US FDA regulations.
* Strong communication and presentation skills (verbal/written).
* A proven self-starter with advanced organisational skills and attention to detail.
* Strong people skills, with ability to work co-operatively and effectively with others.
Remuneration Package
Salary negotiable based on experience.