Job Reference: J5634276
Updated On: 11/01/2021
Status: Now Interviewing
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Role OverviewThis is a fantastic opportunity for a Head of Validation to join a leading Pharmaceutical business based in the Hertfordshire area. Reporting to the Director of Engineering the Head of Validation will be responsible for regulatory and industry standard compliance of all site validation policies, procedures and activities relating to the manufacturing and packaging processes.
Key Duties and ResponsibilitiesYour duties as the Head of Validation will be varied however the key duties and responsibilities are as follows:
1. Responsible for the compliant validation, up to and including Performance Qualification, of all manufacturing based industrial assets. Ensure that the equipment meets regulatory requirements at all times with a target of zero impact to process development, facilities or operational functions. Including the compliant implementation of new systems through the engineering project phase and maintaining compliance of existing systems by delivering appropriate requalification and/or periodic review.
2. Management of all aspects of the equipment validation lifecycle (VMP, specifications, DQ, FAT/SAT, IQ, OQ, Cycle Development, PQ, requalification and/or periodic review). This includes scheduling of the required qualification activities, ensuring local timelines and business Mission Objectives are met. Ensure that risks to product quality throughout the validation lifecycle are understood, transparent and managed through the application of a quality risk management approach.
3. Ownership of the processes (policies, procedures and document management) relating to validation, ensuring compliance with all applicable regulatory and internal quality standards and industry best practice. Ensure they are continuously improved using a risk-based approach, to eliminate waste and improve effectiveness, whilst continuing to align with industry best practices (i.e. ISPE initiatives) and stakeholder requirements.
4.Identify, recruit and manage resources as required, to ensure sufficient and appropriate resource is available to meet agreed timelines. Identify skills and competency development needs of the team and support individual and team development. Manage the performance of the team in line with internal policies and procedures and department strategy.
Role RequirementsTo be successful in your application to this exciting opportunity as the Head of Validation we are looking to identify the following on your profile and past history:
1. Relevant degree qualification in a science or engineering related discipline or equivalent experience within a highly regulated GMP manufacturing environment.
2. You will have recent validation leadership and management experience, specifically leading large validation teams within a pharmaceutical or biotechnology manufacturing environment.
3. Experience supporting validation requirements of large capital projects is essential.
Key Words: Validation | Head of Validation | Validation Manager | Life Science | Pharmaceutical | Biopharmaceutical | GMP | Manufacturing | Quality | QMS | Compliance | Utilities | Equipment | Cleaning | Laboratory | CSV | Process
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
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