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

Responsibilities

• 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.

Qualifications

• 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.