Job Ref: 2566 Recruiter: Tom Doyle
Country: Ireland Location: Dublin
Job Category: Process, Pharma Life Science, Salary Range: €Negotiable

Job Description

Validation Lead (Sterile Laboratory – Not Equipment) Dublin

Kppm are currently looking to recruit a suitable candidate for the role of Validation Lead for our client an international pharmaceutical production company in south west Dublin – Ireland.

Suitable candidates will have a 3rd level Science / Engineering degree (a  formal qualification in Microbiology is highly desirable but not essential) plus  a minimum of 5+ years Sterile process Laboratory (not  equipment) validation experience including:  Micro data, Thermal data and Process SIP.

The Role:

Key responsibilities include but are not limited to the following:

  • Authoring of the site validation master plan, tracking of the sVMP work throughout the year, reporting on progress and generation of sVMP closeout report.
  • Participation in Media Fill activities including review and approval of media fill documents.
  • Review and approval of validation documents for sterilisation qualifications e.g. autoclave qualifications, SIP qualifications and irradiation qualifications.
  • Review and approval of Laboratories equipment and software protocols/reports/URS’ to ensure compliance with current regulatory expectations.
  • Review and approval of validation documents for laboratory method validations.
  • Participate in Change control assessments and deviations investigations.
  • Participate in Process Risk Assessments [FMEA].
  • Act as Validation representative for validation activities in project work involving cross-functional, multi-departmental teams.
  • Participation in external audits and regulatory inspections.

In addition you will also assist the wider validation team in the following areas:

  • Review and approval of validation documents for process and cleaning qualifications.
  • Review and approval of validation documents for thermal qualifications.
  • Review and approval of validation documents for equipment and utilities qualifications.
  • Review and approval of periodic review reports.
  • Preparation of validation training material for relevant personnel and contractors.
  • Proactively driving delivery of the departmental and company objectives and goals.

Furthermore, you are required to be:

  • Passionate and enthusiastic in your way of working.
  • Possess strong attention to detail.
  • A professional with positive and proactive influencing skills.
  • A strong and proactive team player who thrives on working in a fast paced production environment.
  • Possess a positive mind set of safety first.

For further information or to apply in strictest confidence contact: Tom Doyle at kppm.

Email: tom@kppm.ie  Ph: 086 8205038   /  Email: tom@kppm.ie

 

or email tom@kppm.ie

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