Equipment Compliance Specialist

Recruiter
Anonymous
Location
Hertfordshire
Salary
35000.00 - 45000.00 GBP Annual + GBP35000 - GBP45000/annum
Posted
12 May 2017
Closes
27 May 2017
Function
Specialist
Contract Type
Permanent
Hours
Full Time
International Pharmaceutical Manufacturer based in Hertfordshire requires an experienced Equipment Compliance Specialist on day shift Monday to Friday:

• To critically review and approve maintenance and validation documentation for key manufacturing equipment on behalf of QA to ensure compliance with GMP requirements.
Equipment to include but no limited to: autoclaves, tunnel sterilisers, AHT ovens, filling machines, oversealers, freeze driers, chromatography columns, centrifuges, ultrafilters, ILP lines, plasma processing equipment
• To perform regular reviews of the performance of key manufacturing equipment and report adverse trends to Production, Engineering and QA Management
Equipment to include but no limited to: autoclaves, tunnel sterilisers, AHT ovens, filling machines, oversealers, freeze driers, chromatography columns, centrifuges, ultrafilters, ILP lines, plasma processing equipment
• To perform regular reviews of the performance of the critical utilities and report adverse trends to Production, Engineering and QA Management
Utilities to include but not limited to: water systems, steam systems, HVAC
• To represent QA at the following site meetings:
Utilities Review Meeting, Engineering Meeting, Site Validation Committee, Cleaning Steering Committee
• To critically review and approve process validation documentation on behalf of QA to ensure compliance with GMP requirements
• To act as a QA representative for Local Ownership activities for Production Engineering, Site Engineering and Validation and others as required
• To act as a QA reviewer and assist with root cause investigation of deviations concerning validation, utilities and disposable filters
• To act as the QA point of contact for issues involving disposable filters and the management of filter validation
• To act as a QA stakeholder for controlled changes relating to key equipment or validation as required
• To act as a QA representative as required at project meetings or working parties on the modification or replacement of key manufacturing equipment
• To act as a trainer for QA on equipment and validation subjects
• To review and authorise on behalf of QA all Engineering and Validation SOP's, Engineering BEMPs and drawings
• To keep up to date with current GEP / GMP guidance and legalisation to ensure site systems are compliant or aligned to best practice
• To act as QA reviewer for manufacturing batch records as required
• To perform any other duties as required by the business and the QA Director

You will be joining a truly International Manufacturer, offering excellent career development opportunities