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QA Specialist (Sterile-pharma)

Job Title: QA Specialist (Sterile-pharma)
Contract Type: Permanent
Location: Wembley, London
Industry:
Salary: Negotiable
Reference: J905525_1591365587
Contact Name: Hannah Williams
Contact Email: Hannah.Williams@russell-taylor.co.uk
Job Published: June 05, 2020 14:59

Job Description

Role: QA Specialist (sterile-pharma)

Location: Wembley

Salary: DOE

Russell-Taylor Group have a fantastic opportunity for an experienced QA specialist to join a growing Pharmaceutical company. The ideal candidate must have vast GMP experience, extensive experience of the QMS system and already has experience working in a Pharmaceutical environment.

Primary Responsibilities: -

  • Manage and be accountable for quality compliance and in-process QA
  • Be responsible for documentation including area qualification, HVAC qualification & any other relevant validation document
  • Responsible for process validation activities (media fill, autoclave & dry heat oven)
  • Ensure timely completion and compliance to Quality Management System
  • Excellent knowledge in troubleshooting, failure investigation of product & processes & gap analysis
  • Responsible for OOS, OOT, Deviations, complaints, returning of goods and any recalls
  • Knowledge on audit trail review of QC instruments
  • Responsible fo the batch review of all documents and be able to release the batch into the market
  • Undertake and handle internal audits as well as customer audits and regulatory inspections
  • Implement CAPA when necessary with training metrics in place
  • Be responsible for the Risk Management activities

Secondary Responsibilities: -

  • Responsible in preparing the Site Mast Plans & Validation Master Plans
  • Ensure both internal and external requirements
  • Responsible to conduct & review MRMs
  • Review SOPs ,Specification, and STP & GTP as per pharmacopeia
  • Hosting inspections by Regulatory Inspectors, Business Partners & Customers
  • Responsible for supplier qualification
  • Responsible for Software validation

Person:-

  • Very strong experience required in quality
  • Sterile & microbiological exposure
  • Experience working to GMP
  • Experience with the QMS
  • Good exposure to auditing and MHRA, USFDA or TDA
  • Lead Auditor & CSV training certification is desirable

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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