Validation Manager Manufacturing

2 weeks ago

Nottingham, United Kingdom Gi Group Full time

Validation Manager Manufacturing - Pharma or cosmetics
Location: Nottingham
Monday to Friday
Competitive salary and excellent benefits
Our client is part of a world leading contract manufacturer in the Pharmaceuticals and cosmetic fields and manufacture iconic brands from the client brief through to the completed product and sold around the world right from their MHRA and FDA approved factoryin Nottingham. Due to ongoing growth they are seeking a skilled Validation Manager to define the validation strategy, plans and support the compliance of current and new equipment & cleaning/manufacturing/packing processes are fully validated to deliver efficientand reliable results.
KEY RESPONSIBILITIES
Supports the industrialisation process by having a good understanding of the validation techniques and requirement, a pragmatic and rigorous approach of problems and a good sense of team working.
- Implement the validation strategy in the most efficient, compliant and cost effective way.
- Manage a team of validation technicians and potentially contractors.
- Develop validation standards (including sampling plans) to support the business and ensure a quick, easy and compliant validation process.
- Ensure validation activities are completed on time, to the appropriate quality level and on budget.
- Analyse new equipment and cleaning processes to deliver the most efficient and compliant validation plan.
- Support the teams in the building of URS to ensure compliance and good delivery of projects.
- Ensure validation activities are appropriately available on time for quality, customers & regulatory bodies.
- Maintain & disseminate current knowledge of regulatory requirements and industry best practice pertaining to validation.
- Manage all validation activities related to production equipment & cleaning/manufacturing/packing processes, which include the development, writing, execution, review and approval of validation plans, validation protocols and reports (DQ/FAT/SAT/IQ/OQ/PQ/VSRs)etc.
- Evaluate, investigate and document non-conformances incidents and/or protocol deviations related to new equipment & cleaning / manufacturing / packing processes validation
- Complete assigned non-conformance and CAPA investigations and prepare investigation reports related to new equipment & cleaning / manufacturing / packing processes validation.
- Prepares and controls the validation budget.
QUALIFICATIONS
- Science degree or other relevant degree or qualification
- Preferably Lean Sigma trained & certified with good practical experience of its use both in QA & Manufacturing environments.
SKILLS & EXPERIENCE
- 5 years' experience in a validation role in a Manufacturing environment in cosmetics and/or Pharma environment
- Process driven thinking
- Identify critical points in a process
- Managing skills & teamwork (functional & cross-functional)
- Regulatory knowledge (FDA, MHRA, ISO13485, ISO22716)
- Problem solving & solution implementation
- Microbiological & chemical awareness
- Excellent communication skills both written and verbal
- High standard of technical report writing
- The ability to read, analyse and interpret scientific and technical reports and respond to enquiries from regulatory agencies
- Must be able to plan, organise, and implement multiple concurrent tasks.
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated recruitment team and partners with many different Pharmaceutical and Biotechnology and manufacturing clients throughout the globe and the United Kingdom

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