£30000 - £35000 per annum
+44 (0)151 666 8999
about 1 year ago
Specialist role focusing on quality control function being complaint with current good quality control laboratory requirements (GMP and GLP).
What will you being doing?
Your role is integral to the successful operation of the wider QA function. You will be experienced in QC in a lab environment and working with/alongside the QA teams. You will be running Data Integrity Checking; CAPA’s; Deviations; NCR’s; Change Controls and maintaining the incident log internally. You will be ensuring SOP’s and conducting Test Method reviews as well as Procedure Inspections. Your role will include but not be restricted to:
- Assisting with investigation of laboratory incidents, Out Of Specification (OOS) / Out Of Trend (OOT) in order to ensure compliance with the relevant procedures and guidance.
- Coordinating the QC input into Annual Product Quality Reviews (APQRs).
- Write Quality Technical Agreements (QTAs) related to contract laboratory services.
- Reviewing and approve stability protocols prior to the introduction of the stability study as well as stability reports as approval for completion of the stability study.
- Reviewing and approving Quality Control Records and Test Procedures.
- Reviewing existing SOPs covering Quality Control procedures on an as and when basis.
- Performing internal audits of the QC laboratories and ancillary areas.
- Liaising with clients on routine QA matters, and participate in client audits/visits.
- Providing QA support for the specification, introduction and validation of new process equipment and or procedures.
- Leading GMP training sessions.
- Ensuring all laboratory equipment and systems are adequately controlled, calibrated and qualified.
- Reviewing supplied analytical methods and give constructive comments to aid in their introduction and improvement.
- Assist from a QA perspective the transfer of QC Analytical Methods for finished products and raw materials.
- Ideally degree level in a science-based subject or demonstrable equivalent experience within the pharmaceutical industry, to include manufacturing/QA/QC.
- Presentation skills, and the ability to train personnel in quality matters are required
- Strong report writing, statistical evaluation and effective meeting skills.
- A thorough knowledge of the principles of equipment/ process/ analytical/ cleaning validation is required. The job holder requires a thorough knowledge of QC (chemical and microbiological).
Apply on line to be considered for the role or call me Kelly Maddocks on 0151-666-8950
Not sure if this is the right role for you? Get in touch anyway and we can discuss QC/QA roles.
Scantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis.
Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you don’t hear from us within 28 days your application has not been shortlisted at this time, to be considered for future vacancies please register with us on our website.