SENIOR VALIDATION SPECIALIST
12 Month Rolling Contract
A vacancy exists with my client for a Senior Validation Specialist within the Engineering - Projects Department.
Reporting to the Senior Manager Capex Portfolio Project Engineering, the Senior Validation Specialist is responsible for leading all aspects of the Commissioning and Qualification program in order to meet appropriate GMP regulatory and validation requirements. They will be responsible for the review and approval of validation documents such as policies, project master plans, procedures, specifications, investigations, protocols, risk assessments and reports.
The primary tasks of the role include:
· Review and approval of validation documents for Commissioning and Qualification
· Review and approval of validation documents for Utilities qualifications
· Review and approval of the Media Fill protocol and report
· Participate in process Risk Assessments and Validation Assessments as a subject matter expert
· Subject matter expert representative for validation activities in project work involving cross-functional, multi-departmental teams
· Preparation of validation training material for relevant personnel and contractors
· Participation in external audits and regulatory inspections as a subject matter expert
· Proactively driving delivery of the departmental and company objectives and goals
· Keep abreast of latest developments from Regulatory Authorities.
· Assist in other Validation department duties as required
· Take an active role in helping to develop the validation strategy for site and the department by further developing the commissioning and qualification process within LEO Pharma.
The Senior Validation Specialist will be responsible for ensuring that all work performed is in compliance with relevant regulatory requirements, company quality, safety and customer service policies.
The successful candidate will be a strong communicator, passionate and enthusiastic in the way of working, a professional with positive and proactive influencing skills with the ability to take ownership, a strong and proactive team player who thrives on working in an international environment, a professional who can motivate others to adapt to new processes and understand how to build efficient working relationships with both internal and external stakeholders.
The ideal candidate will possess the following:
1. Third level honours qualification in Chemistry / Pharmacy / Biology / Engineering or other appropriate discipline (essential).
2. Minimum of 3 to 5 years' experience in a quality, production or engineering function in the Pharmaceutical Industry desirable
3. Working knowledge of ISPE Baseline Guide 5 Commissioning & Qualification 2nd Edition
4. Excellent communication skills and team oriented with a strategic mindset
5. Fast acting - including an ability to quickly understand and evaluate complex issues and make decisions based on the analysis
6. Achieves results while achieving deadlines
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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