CSV Specialist

303669

CSV Specialist An exciting opportunity for a QC Associate Scientist specializing in CSV. The successful candidate will be an essential part of the team delivering Global Master Projects. The QC Associate Scientist will provide IT compliance/validation support to the team. 

Category:
Commissioning, Qualification, Validation
Location:
Munster
Years of Experience Req.:
3 years +
Date Posted:
20/09/2022
Days Remaining:
30
Employment Type:
Contract
Education Level Req.:
Third level Degree (Level 8)

CSV Specialist

An exciting opportunity for a QC Associate Scientist specializ12173.4622382ing in CSV. The successful candidate will be an essential part of the team delivering Global Master Projects. The QC Associate Scientist will provide IT compliance/validation support to the team. 

 

Qualifications, Skills & Experience Required

  • Degree qualification (Science, Engineering, Technical). 
  • 3 years + and critical skills in their area of expertise.

 

Primary activities/responsibilities:

 

  • Build Global Master Projects, Methods etc.
  • Perform System review activities.
  • Be a key SME for all GmP audits.
  • Supporting quality investigations, CAPA’s & change controls, as required.
  • Consulting in lab-based investigations involving the use of problem solving and root cause analysis methodologies.
  • Providing training, mentoring and guidance as required.
  • Providing ongoing ITcompliance/CSV coaching and support.
  • Participate and comply with FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals (in particular 21CFR Part 11 and Data Integrity requirements).

 

Extensive technical, operational and business expertise in the following disciplines:

  • Computer Systems Validation
  • Project Management
  • Demonstrable analytical and systematic problem-solving skills.

 

DPS Engineering is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.

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