Job Title: Validation Specialist
Department: Validation and Packaging Technology
Reporting to: Principal Validation Specialist or Senior Validation Specialist
Responsible for (staff): N/A
General Purpose of Role:
- To ensure the complete delivery of fully compliant qualification and validation of appropriate equipment, software, facilities, cleaning processes and operational manufacturing processes on site.
- Responsible for ensuring the cGMP compliant delivery of Commercial NPI projects for internal and external clients in accordance with agreed service levels.
- To communicate effectively with internal and external customers and participate with them in problem solving activities.
- Ensure that up to date and relevant artwork and packaging engineering solutions and technologies are employed when working on new projects.
- Work with the Technical Projects group for implementation of new packaging concepts for clinical and commercial projects.
- Consult with Operational groups for packaging optimisation and performance for project specific delivery
- Technical transfer and scale up development of new projects coming into the operational group from FD and client groups for manufacturing and packaging activities.
- Responsible for progressing and assisting in process validation exercises.
- Identification of line and process improvements and performance data gathering with Pareto analysis for new products.
- Adhere to project and deadline timelines and attend the relevant meetings for all client enquiries, scoping and costing, proposals and project initiations.
- Responsible for providing details into the Site Capex process. Responsible for ensuring that key resources and work centres are measured with continuous improvement opportunities identified to improve operational efficiencies and lead times for new products
- To assist in and host client and regulatory audits as required.
- When required, help support, progress and populate Technical Specifications, Master Batch documents, handwritten data and the raising of Works Orders and Pick lists for NPI.
- To comply with company policies including internal and external Health and Safety and Environmental standards as required.
- To identify self-development needs for future performance.
- To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.
- Responsible for all appropriate documentation such as Change Controls, Deviations that may be required for NPI.
- Where required provide assistance to other roles within the Technical Transfer Groups or Manufacturing as required.
- The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
GMP Requirements Hierarchy
- GMP Skill Level 1 is essential for this role (further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)
- Qualified to at least first degree level in an Engineering or Science based subject.
Previous Work Experience:
- Several years’ experience within the pharmaceutical or related industry.
- A strong Continuous Improvement ethos is required and the ability to lead CI teams
Specific Knowledge / Skills Competence:
- The role demands a high level of technical and regulatory knowledge, high standards of attention to detail and the desire to see tasks through to completion.
- Must be able to effectively manage multiple tasks simultaneously
- Strong experience in Pharmaceutical Project Management
- A strong problem solving ability is needed to identify and eliminate validation / qualification related issues.
- Ability to influence and collaborate at all levels in order to achieve company targets.
- Ability to represent the company in a professional and highly competent manner.
- Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
Ability to travel on company business as required.
April 19, 2018