ProClinical is seeking a QA Associate for a growing and successful business comprised of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. This QA Associate role will be based in Reading on a permanent basis.
This is a great opportunity to join their Quality Assurance team as a QA Associate based at their site in Berkshire.
In this role the successful candidate will need to ensure that all operations are compliant with internal procedures and regulatory requirements. You will also support in the provision and development of efficient and effective QA systems for analytical testing and IMP manufacture.
- Writing, reviewing and approving SOPs
- Review and approval of analytical and manufacturing documentation prior to QP certification
- Review of analytical protocols, results and investigations, ensuring data integrity
- Performing audits to monitor compliance of internal operations with internal procedures and regulatory requirements
- Participation in the change control process to ensure changes to processes, systems, equipment and facilities are appropriately assessed and implemented
- Involvement in co-ordinating sponsor GMP audits, co-ordination of responses and follow up of corrective and preventative actions
- Involvement in quality issue investigations and agreeing CAPAs
- Development and implementation of the company quality system as required
- Interpretation and communication of information (e.g. GMP requirements) and provision of advice on quality issues to members of staff and clients
- Review and approval of validation activities such as equipment and computer systems validations
- Involvement in regulatory inspections and sponsor audits as required
Skills and Requirements:
- Ideally from an analytical background
- Experience of working within a GMP environment
- Experience of auditing to GMP standards
- Science based degree preferred but willing to consider other equivalent training or vocational experience
- Good Computer literacy, high attention to detail and accuracy
- Some exposure to pharmaceutical manufacturing would be an advantage.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Will Hitchcock on +44 203 0789 554 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
This job was originally posted as www.totaljobs.com/job/81472349