- Llandysul, Wales
- 01267 610902 or email@example.com
QA Officer up to £24k, Wales
To support the effective functioning of the Quality Management System and provide assistance to the Quality Assurance Department, and wider site team, as required.
- To complete activities required for the preparation of the disposition of finished product by Qualified Persons.
- To review, check and approve completed batch and ancillary quality documentation to ensure compliance with GXP.
- Prepare any required corrective and preventative actions related to the release of finished product.
- Generate Certificates of Analysis and statements of GMP Compliance.
- To support the release, shipment, quarantine and rejection procedures for drug substance and finished product.
- Support the product recall procedure.
- Execute timely review and release of cleaning, solution, bulk immunogens and Drug Substance within company timelines.
- To administer the customer enquiries and complaints system and ensure timely investigation and closure.
- To ensure key quality performance indicators are prepared and trended for the daily meetings, monthly quality management reviews and annual product reviews.
- Support the continual positive development of existing quality management systems.
- Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with the Client’s values. Carry out other reasonable tasks as required by the Line Manager.
- Accountable to – Sr. QA Manager – Qualified Person.
- Internal – Liaise with all departments and Client sites as necessary.
- External – Maintain external contacts e.g. suppliers, contract facilities and distributors, where appropriate.
Education and Experience
- Educational background should be supported by proven experience in an appropriate Quality role within the Pharmaceutical / Biotechnology industry.
- Proficient in Microsoft Office (Word, Excel, PowerPoint).
Skills and Attributes
- A competent, highly organised individual who pays strict attention to detail.
- Excellent interpersonal skills with the ability to articulate views clearly.
- Creative thinker able to solve problems and consider innovative solutions to complex issues.
- Performance driven and customer focussed individual who is comfortable working within multi-disciplined teams.
- Must be self-motivated with the ability to handle multiple tasks simultaneously.
To apply for this job please fill in the form below. You can also upload your CV to support your application.