|Lead Validation SME
Reporting to the Site Head you will develop, plan, implement and manage Site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements and related SOPs. You will be the MS&T Validation Lead for the Cork Site.
- Establish, generate and, maintain Site Validation Master Plan and associated technical SOPs for all validation, revalidation and periodic review activities on-site.
- Support Site Head in ensuring that responsible departments execute and maintain the VMP activities including, annual revalidation process to the required technical standards.
- Assess and approve Change Control proposals to ensure validation strategy is consistent with validation requirements.
- Establish and manage the individual project validation plans by aligning, coordinating and supervising the prioritisation of activities against the business needs.
- Maintain governance of all validation activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities.
- Advise validation practitioners on all aspects of validation planning, testing strategy and execution.
- Identification of future budgetary requirements for the area
- Manage costs within budget and identify & implement productivity improvement opportunities.
- Support equipment and process qualification for new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering.
- Provide assessment of and input to Quality Modules (QM)/Quality Directives (QD)/global Standard Operating Procedures (SOPs) and Technical Guidance Documents (TGDs) to ensure documents are in line with global/local requirements and industry standards.
- Participate in improvement and remediation of products.
- Liaise with external customers and other Client sites as part of daily role.
- Leadership experience - a distinct advantage
- 10 years' + of relevant experience and bachelor's degree in science or related field.
- In-depth understanding and application of validation principles, concepts, practices, and standards.
- Proficient in current Good Manufacturing Practices (GMPs).
- Extensive working knowledge of equipment and systems- specifically packaging & serialization operations.
- Demonstrated investigation and report writing skills.
- Root Cause Analysis tools and operational excellence mindset.
- Proficient in Microsoft Office applications
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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