QA Specialist - GDP

ProClincial is seeking a QA Specialist to be based in Leicester on a permanent basis. This QA Specialist role will ensure that goods are appropriately purchased, transported, receipted and despatched in line with EU Good Distribution Practice regulations and UK regulations. Also supporting QA activity and GMP activity as required.

Job Responsibilities:

• On advice of a new order; carry out and document checks to ensure that purchases are made from only appropriately approved suppliers, and that importation of any unlicensed product is correctly processed with relevant licences received prior to import. Liaise with procurement and QA as appropriate.
• Apply for, and complete controlled drug licences if required for import into UK.
• Liaise with QP as needed for batches requiring release including provision of documentation for QP review and maintaining Certificate of Batch Release (COBR).
• Check warehouse / pre-wholesaler Goods Received documentation, including temperature readings and assist in the investigation of any temperature excursion.
• For any non-conforming materials or deviations, liaise with QA to ensure all required documents are made available and assist in investigation and resolution where required.
• Manage any return of product back to the supplier and ensure applicable documents are completed.
• Carry out and document checks to ensure that customers and delivery sites are appropriately verified to handle the medicinal product(s) and that import procedures in third countries are met. Liaise with customer facing person and QA as appropriate.
• Apply for, and complete controlled drug licences if required for export out of UK.
• Liaise with Logistics for collection of outgoing shipments, and complete all associated paperwork, including Instructions on Shipment.
• Obtain copies of shipping documents, which include airway bills (AWB), master airway bills (MAWB), proof of collection (email), proof of delivery (POD) and temperature data (if applicable).
• Check and process approved requests for customer returns, liaising with the customer and supplier as appropriate. Maintain a document trail.
• Inspect and release GMP starting materials.
• Issue printed packaging material for secondary packaging / relabelling activity.
• Carry out QC in-process checks during GMP secondary packaging / relabelling activity.
• QC outgoing shipments (second check) where required.
• Maintain GMDP related indexes and files.

Skills and Requirements:

• "A" levels or equivalent.
• Minimum of 2 years administrative experience.
• Experience in a similar position within a pharmaceutical environment is desirable.
• Excellent organisational and communication skills (both written and verbal)
• Accuracy and detail oriented
• Ability to multi-task
• Computer skills: Microsoft (Word, Excel), Outlook.

To Apply:

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 Courtney Russell on +44 203 8141 315 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.