Contract Process Validation consultant

Employer
Umbilical Life
Location
North Yorkshire (GB)
Salary
Negotiable
Closing date
1 Oct 2020

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Contract
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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.

Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering. 

Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.

With nearly 75 years of workforce industry experience between us we know a lot, but not everything. 

We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.   

 

Contact Us
  • Premier House
  • 9 Rutland Street
  • LE1 1RE
  • GB
  • 011 6 461 0070
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