QA Auditor - London / Kent
Jason Johal is currently recruiting for a QA Auditor to join a global pharmaceutical company that designs and supports advanced coating systems, modified release technologies and functional excipients for pharmaceutical dosage forms. The role is based at the UK site in London/Kent on a full time permanent basis and a rotational two shift pattern (6am-2pm, 2pm-10pm (20:30 finish on a Friday)) with a salary up to £30,000 + 17.5% shift allowance.
The QA Auditor will be responsible for the full auditing of batch documentation and data within Oracle to ensure compliance with manufacturing standards for products made by the company within the EMEA. They will also be responsible for auditing manufactured and raw material batches to the relevant standards and the release of finished goods within Oracle after successful auditing.
Other responsibilities in this role will be to:
- Audit batch documentation packages for compliance prior to release of product for sale including the review and approval of QC results within Oracle.
- Conduct plant and QC inspections to ensure that procedures and practices are being adhered to when required.
- Review and generate production batch documentation of RP batches prior to release.
- Correct entry of appropriate data into the company Oracle computer system for the release of batches for manufacture and subsequent approval for packing.
- Change status of raw material deliveries in the Oracle system as indicated by completed raw material data packages.
- Liaise with colleagues in other departments, share data and provide QA documents when required.
- Conduct GMP audits when required in line with the companies yearly audit requirements.
- Maintain FTR & FTQ data for management reporting and analysis.
- Ensure all tasks are carried out in compliance with company ISO, GMP and Health and Safety procedures.
- Promote continuous improvement within the department and provide support to other departments in improvement activities.
You are required to have the following qualifications, skills and experience:
- Strong auditing skills and a good understanding of Oracle.
- A good understanding of the requirements of ISO9001:2008 and, cGMP.
- Strong experience gained within a busy Quality Assurance Department.
- General awareness of Quality Assurance and Quality Management Systems.
- It is essential that you are able to undertake data analysis and trending.
- Knowledge of Lean Techniques, continuous improvement and problem solving tools.
- Ideally you will be a qualified Auditor to the requirements of ISO9001:2008 & cGMP (not essential).
- A firm understanding of QC laboratory practices.
- Project planning experience.
- Educated to Degree level or equivalent.
If you are employed by this client you will be joining a firm committed to providing best-in-class pharmaceutical products and services to support all phases of solid dose design and development, along with superior technical support dedicated to meeting customers' needs.
Other benefits include:
- Private Medical Cover.
- Private Dental Cover.
- Company Pension Scheme (stakeholder).
- Company Bonus Scheme 3% (non-contractual).
- Spot Bonus Scheme.
- Employee Assistance Programme.
- Subsidised Staff Restaurant.
- Training and Development.
- Long Service Awards.
- Child Care Vouchers (provider is Edenred).
- Payroll Giving Scheme.
For more information or to apply for this position, please contact Jason Johal on 01438 723500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45064 in all correspondence.