Our client is is a fast growing, contract pharmaceutical development company working with customers all over the world to develop new pharmaceuticals and biotechnology products for a wide variety of disease indications in both adults and children. They are seeking a Quality Assurance Officer.
What you'll do: The Quality Assurance Officer role is a critical part of the business providing an essential part of the QA team. QA Officers are expected to work closely with the Production, Lab, Product Development, Project Manager and Business Development teams. The role involves a split between document review and approval and QA support to the production facility. The role will involve regular entry into the GMP suite to assist with the QA support for ongoing batch activities.
Your background: Candidates should possess a scientific or pharmaceutical production background (degree in scientific or pharmaceutical science preferred) and an understanding of Good Manufacturing Practice and its application. Prior experience of Quality Assurance is preferred but not essential.
Essential skills for the role are a good level of attention to detail, good organisation and interpersonal skills. The ideal candidate would be a good team player but with the confidence and ability to represent the department in project meetings. Whilst previous QA experience in pharmaceuticals is preferred, the critical attributes for the role are enthusiasm and a positive attitude.
Day to day activities may include the following:
- Checking and approving Batch Manufacturing records
- Checking updates to documents such as Standard Operating Procedures
- Reviewing and advising on deviations
- Preparation of dossiers for Qualified Person approval
- Presence in Production areas to review documentation, perform line clearances and perform QA checks
- Checking and reviewing of Lab data and specifications
- Assisting with internal audits and Client audits
Key Performance Areas will be:
- Timely sign off of documentation to meet QP release dates
- Enable successful completion of corrective and preventative actions
- Accurate review of documentation to prevent deviations and customer complaints
On this occasion, LiCa Scientific is acting as an employment agency.