QA Specialist & Responsible Person
Join our growing Quality Team here at Acorn Regulatory as we are looking to hire a Quality Specialist/Responsible Person.
Location: Flexibility to work remotely
- Support the Quality team with the maintenance of the company’s QMS;
- Ensuring compliance to ISO 9001, GMP and GDP requirements and internal procedures;
- Raising deviations, CAPA’s, change requests and maintaining other elements of a quality system;
- Analysis of process performance and preparation of Quality Management review meetings;
- Ensuring compliance to Internal Audit schedules, executing internal audits;
- Ensuring continual improvement, maintenance of internal KPIs;
- Ensure compliance with the requirements of GDP and other relevant guidelines;
- Ensure conditions of the Wholesale Distribution Authorisation are met and that all medicinal products wholesaled, are received, stored, transported, and delivered under strict GDP conditions;
- Conducting bona fides of suppliers/customers.
- B.Sc. in a Life Science related discipline as a minimum
- A minimum of 5 years’ experience in the area of Quality Assurance and/or Responsible Person.
- Experience and comprehensive knowledge of ISO 9001 standard, GMP and GDP Guidelines.
- Relevant auditing and/or quality qualification would be an advantage.
- Experience in the preparation of audit planning, execution, report writing and follow up.
- Ability to project manage and multi-task workload and client work.
To apply for this job email your details to firstname.lastname@example.org.