About the Position
* Co-ordinate Complaints/Quality Defect Reporting Systems and lead investigations to ensure effective CAPA implementation.
* Collaborate with relevant parties to identify and address issues impacting product quality, safety, efficacy, regulatory compliance, or business continuity.
* Conduct thorough root cause analyses and manage Quality Risk Management exercises to document findings and implement corrective actions.
* Coordinate local regulatory activities, including Site Master File maintenance and updates.
* Develop and maintain Supplier Quality Management Systems through supplier audits, documentation reviews, and Quality Agreement generation.
* Assist in site regulatory audit readiness programs by managing front room operations, collating audit responses, and implementing CAPA.
* Support QP certification activities, including batch record reviews and IMP Order authorisation.
Experience Requirements:
* Bachelor's degree in a science or quality-related discipline.
* Minimum 10 years' experience in pharmaceutical finished drug product manufacturing with knowledge of EU GMP, US FDA, and other regulations.
* Excellent understanding of current and pending EU GMP and US FDA regulations.
* Strong communication, presentation, and organisational skills with attention to detail.
* Proven ability to work cooperatively and establish good working relationships.
Remuneration Package:
Salary negotiable based on experience.