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Lead CSV Engineer

I7662

DPS are seeking a Lead CSV Engineer for a 24 month project on a Cork-based Biopharma client

Category:
Engineer Electrical
Location:
Munster
Years of Experience Req.:
5+
Date Posted:
12/09/2019
Days Remaining:
26
Employment Type:
See Description

DPS are seeking a Lead CSV Engineer for a 24 month project on a Cork-based Biopharma client  

Main Purpose and Objectives:

  1. Provides Quality leadership, direction and governance for the specific area of responsibility.
  2. Manages quality-related matters specific to area (Quality System or Quality Program) of responsibility.
  3. Is responsible for approving appropriate quality-related documents. An approval signature confirms that and GMP requirements have been met.
  4. Establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.
  5. Is responsible for providing consulting, training and feedback to site and corporate personnel and projects, and lead compliance to computer system quality standards.
  6. Maintenance of all aspects of GMP / CSQ compliance for the area(s) of responsibility
  7. Provide guidance, review and approval for all computer related validation documentation.
  8. Documents resulting from CSVP and other CSQ processes across all site systems, laboratories, process automation and IT.
  9. As policy is set by the Corporate QA organiz456896.580554ation, help site consistently interpret and implement the policies across all Computer Systems areas (e.g., IT, Process Automation, Lab Automation)
  10. Reports and escalates critical quality issues to the appropriate level of quality management for final resolution

If you are interested in hearing more about this role, please apply through the link below!

DPS is a leading Project Management and Engineering Company delivering Full Service Engineering with a ‘client first’ mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time. 

We’ve been serving industry around the world for 40 years plus, relied on for our agility, original thinking, sound judgement and high-calibre people. What sets us apart is the rapport we build with our clients and the care we take to gain a fundamental understanding of our client’s businesses. We employ over 1600+ people out of our fifteen office locations and we serve a broad range of clients ranging from multinational companies to small generic producers. DPS Engineering is an Equal Opportunities Employer

Recruitment Agencies: Please do not reply to this job advert

Skills:

Computer System Validation, 21 CFR Part 11, CSV

 

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