Contract Process Validation consultant

Michael Parker at Umbilical Life is currently recruiting a contract process validation consultant. The contract will be based onsite in North Yorkshire paying competitive rates for a 5 day per week initial 6-month contract.

This is an urgent role will a shortlist been submitted this week and interviews expecting to happen from next week.

The client is a large pharmaceutical manufacturing company who predominantly manufacture solid dose. They have a huge amount of investment and expansion going on at the moment so are looking to get some new and improved ideas from experienced validation experts.

The ideal candidate will have 8+ years’ experience in Validation and have experience working on a remediation type projects or similar work.

Some of the key responsibly & requirements are:

• Responsible for ensuring that the validation standards applied meet business and regulatory standards.
• Representing the company during regulatory and client inspections on all matters relating to manufacturing process validations.
• Address audit findings and support continuous improvement and CAPA (corrective action/preventive action) activities related to manufacturing process validations as assigned.
• Work with internal manufacturing teams to create user requirements specifications (URS) for manufacturing equipment.
• Act as a subject matter expert and provide consultation for other sites/departments with key users.
• Contribute to the generation and review of required documentation (SOPs, Protocols, Change Requests/Change Controls, URS, deviations) to support validation activities.
• Provide adequate reporting and communication of projects to project manager, stakeholders and/or department managers.
• Management of the aspects of the Quality and Risk Management system relating to validation activities.
• Sponsor and review change controls.
• Working collaboratively across the business to ensure that Validation-related processes and procedures are well-represented in regulatory submissions and responses to regulatory agencies
• Engaging with strategic partners and collaborators in promoting the Company’s credibility in relation to qualification/validation activities
• Ensuring validation master plans (VMPs), programs of work, protocols and procedures are established which facilitate the delivery of qualification/re-qualification/validation activities to the required quality and regulatory standards
• Maintaining an active awareness of developments in regulatory standards and industry best practices which may impact qualification and validation requirements.
• Identify risks and implement changes to ensure compliance with GMP regulatory requirements
• To manage regulatory impact assessments on new and emerging requirements in order to determine the actions required to ensure proactive compliance.
• Closely partner with customers and internal stakeholders to adapt the validation program to meet applicable regulatory requirements.
• Provide expertise and support by participating in internal and external audits (customer/regulatory).
• Support other validation activities as required.