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QC Compliance Specialist - c£30k Pharmaceuticals MCR

QC Compliance Specialist - c£30k Pharmaceuticals MCR

Posted 2 May by Science Solutions Recruitment Ltd Ended

Science Solutions - QC Compliance Specialist - Pharmaceuticals - Manchester - c£30k

Excellent opportunity with a Global Pharmaceutical Organisation

Ideally we are looking for 5 years in Pharmaceutical finished product QC for Solid Dose (Raw Materials, Stability Analysis) with experience of OOS/OOT & Annual Product Quality Reviews

Specific Responsibilities;

  • To assist with investigation of laboratory incidents, Out Of Specification (OOS) / Out Of Trend (OOT) in order to ensure compliance with the relevant procedures and guidance.
  • To coordinate the QC input into Annual Product Quality Reviews (APQRs).
  • Write Quality Technical Agreements (QTAs) related to contract laboratory services.
  • To review 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.
  • To review and approve Quality Control Records and Test Procedures.
  • To review existing SOPs covering Quality Control procedures on an as and when basis.
  • To perform internal audits of the QC laboratories and ancillary areas.
  • To liaise with clients on routine QA matters, and participate in client audits/visits.
  • To provide QA support for the specification, introduction and validation of new process equipment and or procedures.
  • To lead GMP training sessions.
  • Ensure all laboratory equipment and systems are adequately controlled, calibrated and qualified.
  • To review 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.

Requirements;

  • The job holder must be educated to degree level in a science-based subject or demonstrable equivalent experience, with a minimum of 5 years' experience in the pharmaceutical industry, to include manufacturing/QA/QC.
  • Presentation skills, and the ability to train personnel in quality matters are required
  • The job holder should have good 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).
  • The job holder requires good computer skills, and must be able to produce structured technically detailed documents using Microsoft Word, Excel etc.

Please apply now to be reviewed immediately

Required skills

  • QA
  • QC
  • OOS
  • OOT
  • PQR
  • QUALITY REVIEW
  • OUT OF SPEC
  • OUT OF TREND

Reference: 35049469

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