This is a fantastic oppotunity for Quality Assurance Officer to join a renowned Pharmaceutical Company based in North Yorkshire on a permanent basis.
Main Purpose of job:
To support the Quality Manager in maintaining the Quality Systems, and to assist in verifying that products are manufactured in accordance with the relevant Marketing Authorisations and to the requirements of Good Manufacturing Practice.
Main Duties:
1) Issue of Sub-master batch documentation and Master “specials” Documentation to the Planning Department.
2) Archiving batch documentation.
3) Issue and reconciliation of Product Formulation Sheets Batch Manufacturing Record, Analytical Records,SOP's and other GMP Documentation.
4) To assist in compiling and writing Standard Operating Procedures with the relevant departments, new/revised batch manufacturing records and other GMP documentation.
5) To maintain the Change Control system i.e. Documentation within the Quality Management System, SOPs. Formulations etc Including dealing with purchasing based technical problems (i.e. change of supplier, change of components etc in a timely manner and consult and follow up with the QA Technical dept if necessary)
6) To maintain and assist with the Corrective and Preventive Actions systems, Deviations, Out of Specification, Complaints.
7) To maintain the Approved Supplier List
8) To assist in the maintenance of the department indicators and trends.
9) Generation of Certificates of Analysis for Finished Products.
10) To assist in the review of Batch Records prior to release and certification by the Qualified Person.
11) To assist in the auditing the Quality Systems within the company
12) Assist in maintaining the AS400 /Oracle systems.
13) To perform other duties as may be requested and agreed to meet company departmental needs
Salary:
£17-21k |
