Job Description
Our client is a highly profitable fast growing multinational biologics manufacturer based in Dublin, now seek a Validation Manager who will work as part of the QA Engineering group providing oversight for the design, commissioning and qualification elements of the construction of the Drug Substance manufacturing plant.
The successful candidate will is the point of contact for QA Engineering Teams for Qualification / Validation related matters during facility construction and qualification. This hire will communicate updates to management as required managing and supporting the contracted team associated with the design, build and overall qualification of the facility.
This is an 11 month rolling contract position with project estimated to run for 3 years.
Responsibilities of Validation Manager:
- Manage Validation oversight of drug substance facility qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
- Providing key input to the design, planning, execution and reporting phases of the qualification and validation activities associated with the facility build.
- Review and Approve shire and contractor documentation associated with the design, planning, executing and reporting of associated Qualification / Validation activities.
- Gain alignment within the overall company, through planned or ad hoc communication, on the various project strategies as part of the overall facility design / qualification process.
- Manage the validation / qualification efforts and ensure they are executed to agreed timelines.
- Representing the company at project meetings and providing escalation of project issues to management in a timely manner
- Ensure any investigations / deviations associated with the qualification activities are thoroughly investigated and closed in a timely manner
- Provide weekly progress reports.
Requirements for Validation Manager:
- Bachelor Degree in Sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc.).
- 10+ years? experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
- Management experience of large teams and associated project timelines is required.
- Strong experience with Validation in project related activities, including Controlled Area Facilities.
- Lead experience in Validation Planning and Maintenance to ensure compliance to Annex 15 and applicable US FDA Guidelines.
- Experience with planning and execution of Cleaning Validation studies in multi-product facilities.
- Knowledge of/experience with aseptic processing and biologicals.
- Strong experience of CSV regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
- Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
- Track record of utilising Risk Based Approaches to Qualification / Validation activities.
- Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.
This role will require 20% travel to facility.
Please contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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Key words: Commissioning, Validation, IQ, OQ, PQ, New facility build, project management, QA Management, Quality Assurance Manager, Quality Management, Process Validation, Equipment Validation, Biologics, Pharmaceutical, Dublin, Ireland.