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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