A Day in the Life of our Quality Assurance Analyst
To review batch documentation ensuring it is completed right first time and in full, in accordance with product licences, specifications and cGMPs.
To prepare, review and approve documents and reports to ensure compliance with regulatory guidelines.
To archive QA batch documentation.
To complete post QP batch related activities for customers.
To review, maintain and audit documents and processes in an efficient and timely manner in order to meet customer requirements both internal and external and ensure schedule adherence.
To act as a point of contact for external customers and to ensure all customers’ requirements are met in a timely manner.
To identify and make recommendations for improvements as part of a team within or outside the department in order to eliminate non value added activities and ensure continuous improvement.
To carry out audits to ensure that all operational processes are carried out in compliance with the required standards conforming to Company GMP, GLP, SOP, Specifications and Validation requirements.
To provide support for complaint investigation response and approval.
To track and support the CAPA system to maintain site compliance.
Who we are looking for
Are you….
Educated to Degree Level in a science related discipline and/or relevant experience in the healthcare industry
Do you have….
Knowledge of cGMP, regulatory bodies, customer requirements and environmental procedures.
Knowledge of Company policies, procedures and standards
Knowledge of production and Lab process and systems.
Knowledge of internal customers and suppliers.
Auditing skills.
Report writing experience
Documentation completion experience
Problem solving skills and process improvement experience
Teamwork/Collaboration Skills
Excellent planning and organisation skills
Good problem solving skills
