Validation Specialist

Are you a interested in working for one of the Swiss leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!

TITLE: Validation Specialist

RATE: Negotiable

LOCATION: Switzerland

POSITIONS AVAILABLE: 1

TYPE: Contract (6 months)

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

The proposed start date is ASAP- We need YOU

Responsibilities include:

- To define and implement the qualification strategy to establish and maintain the validated status of facilities, utilities, equipment and processes. To lead the validation activities associated with specific projects.
- Ensure the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance/standards.
- Define and execute the validation strategy associated with site projects covering a range of a range of facilities, utilities, equipment and processes in accordance with project timelines and customer expectations.
- Define the validation testing strategy for requalification/revalidation activities. Execute requalification, revalidation and periodic review activities in accordance with the Validation Master Plan schedule.
- Subject matter expert for specific areas of validation as defined by the Validation Manager.
- Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation. This includes changes to corporate quality guidance and standards.
- Identification and implementation of continuous improvement initiatives to ensure lean ways of working. Regularly leads departmental continuous improvement projects to ensure a lean validation life cycle.
- Drive a risk based validation life cycle utilising quality risk management principles and tools (eg FMEA, HAZOP) to ensure that risks are appropriately identified and documented.
- Provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification/(re)validation activities and site Unplanned Events
- Present validation packages during regulatory/internal/customer audits. Participate in the response to regulatory audit observations (as required)
- Participate in the vendor selection process and provide guidance/advice on system selection.
- Review proposed Change Controls (low to mid complex changes) to assess the impact on the validated status and determine the validation strategy as required.
- Liaise with vendors to ensure the correct standards are delivered to facilitate an integrated approach to commissioning and qualification.
- Provide co-ordination and leadership of individual contract resource (as required). Regularly provide oversight of contract/vendor resource on an individual project basis to ensure validation activities are delivered in compliance with site procedures and in accordance with the project schedule.
- Generation, peer review and approval of technical documentation.
- Generation and maintenance of Validation Plans and Validation Master Plans.
- Provision of data to support departmental Key Performance Indicators (as required).
- Support the training and development of junior members of the Validation n team to enhance the level of experience and expertise.
- Deputise for Validation Expert (as required).

Requirements

- Good understanding of the regulatory requirements and current industry standards/best practices pertaining to validation.
- Degree in a relevant life sciences or engineering discipline
- Ability to demonstrate Continuous Professional Development in regard to Qualification
- Subject Matter Expert with an excellent technical, compliance and practical understanding of specific aspects of validation as defined by the Validation Manager.
- Sound understanding of aseptic processes and associated process equipment.
- Good understanding of quality risk assessment principles and tools and their application throughout a risk based qualification life cycle.
- A natural tendency to continuous improvement. Basic/good understanding of the foundation principles of Lean Six Sigma.
- Experience of presenting during regulatory audits including FDA and MHRA.
- Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for supporting regulatory submission.
- Critical analysis of a wide variety of raw data types in order to give clear reasoned and objective based outcomes.
- Organised, target orientated, customer focussed, clear communicator, ability to deal with people at all levels, lateral thinker, good negotiator, ability to prioritise, ability to balance objectives.
- Able to work effectively as a part of a cross-functional team and maintain good relationships with internal and external stakeholders.

If you are interested please do not hesitate to email or call me!

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