Company: Hydrogen Group
Closing Date: 13 Mar 17
Salary (£): Negotiable
Summary:Our client based in Basel, Switzerland is looking for a highly skilled CQV engineer to join there team. They are looking for a dedicated, self-motivated engineer that can work well in a team with a broad knowledge of the pharmaceutical and/or medical device industry.
* Lead and coordinate all QRAES (Quality Risk Assessments) for all related Systems ensuring all critical aspects are addressed and Final Report issued.
* Liaise with Document Preparation Lead in relation to all Document Deliverables and Approvals, the output of Documents will be controlled by the Document Generation Tracker, which will generate Milestones and Durations, of which, the Lead will be measured against.
* Lead and coordinate Verification Design deliverables (Enhanced Design Review / Design Qualification)
* Review and approval of all Vendor Documentation
* Lead for all Factory Acceptance Testing Liaise with Document Preparation Lead in relation to producing Protocols (FAT/IV/SAT/FV). Liaise with vendors / suppliers in relation to GEP and GDP requirements for leverage-able test documentation Liaise with RV Lead to ensure all RV deliverables are executed as per Project Procedures
* Assist where applicable in Quality Audits for all vendors / suppliers
* Lead for all FV deliverables = Start-up, De-bugging, Automation Checkout (ACO), Site Acceptance Test (SAT), Phase and Recipe Testing ? Manage the timely closure of all CQV Punch list items
* Liaise and utilize Engineering Change Management System (ECM)
* Review and approval of all Vendor Turnover Packages and Field Turnover Packages against the VDR and to ensure these support the Validation Requirements for the system Lead for Mechanical Completion acceptance and Walk downs.
* Prioritise qualification activities in line with the project schedules and business needs
* Prepare CSRs (Commissioning Summary Reports) for executed documentation
* Ensure all the requirements for the IOQ summary reports are available and the good engineering and documentation practices have been followed throughout.
* Review all vendor and site change controls for impact to the completed testing as required.
* Liaise with QA in close-out of all CQV deviations and exceptions
* Generate Project specific SOP's / other documentation as applicable
* Support CQV and QA programmes as required
• A minimum of 3 years’ experience in a process or start-up role in the pharmaceutical industry.
• Literate in computer operating systems and applications such as Windows, MS Word and Excel.
• Qualified with relevant technology degree (or equivalent).
• Operating experience in the pharmaceutical industry, ideally in a biotechnology process environment.
• Knowledge of process & clean utility design.
• Good understanding of the regulatory compliance requirements (EMEA/FDA) for pharmaceutical operations.
Personal / Team Skills:
• Results oriented engineer with good organisational skills.
• Strong quality and safety focus
• Excellent communication skills
• Previous experience working in a team based environment
• Identifies him/herself with the philosophy of the plant.
30 Eastcheap London
|Tel:||+44 (0) 207 002 0000|
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