Validation Consultant

Job Ref: J23908
Sector: Science
Sub-sector: Biotech/Life Sciences
Date Added: 13 October 2017
  • Oxfordshire, England, UK
  • £35,000 - £45,000 per Annum
  • Andrew Shortt
  • 0121 222 5333

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Interim Validation Consultant

Oxford

Up to £45,000, depending on experience

6 month contract

My client's facility is a GMP (Good Manufacturing Practice) manufacturing facility, where the basic research into potential advanced therapies can be translated into an Investigational Medicinal Product (IMP) used in first in man clinical trials. My client has 20 years' experience producing biological IMPs according to GMP for early phase clinical trials. They have a Manufacturer's Authorisation for Investigational Medicinal Products (MA IMPs) from the Medicines and Healthcare Products Regulatory Agency (MHRA) and is currently manufacturing novel vaccines and therapies.

The responsibilities below will be undertaken as required, further to ongoing discussions with the Senior QP, where priorities will be established and targets set and regularly reviewed.

Validation Activities:

  • Using a Quality Risk Management approach, establish a revised policy and set of procedures for
  • validation and qualification activities for facilities, equipment, utilities and processes as is required,
  • ensuring compliance with EU GMP Annex 15 and EU GMP Annex 11 for any computerised systems
  • Produce a set of master documents covering all aspects of validation including User Requirement
  • Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational
  • Qualification (OQ) and Performance Qualification (PQ)
  • Develop protocols for re qualification
  • Compile the annual Validation Master Plan (VMP)
  • Review any validation paperwork completed by staff or contractors
  • Design and deliver specific training sessions for all staff on Validation

Business Impact:

  • Proactively carry out reviews of processes by using tools such as process mapping to identify any deficiencies and opportunities for improvement
  • Implement strategies for streamlining and improving processes to enhance efficiency, while ensuring compatibility with GMP and other relevant legal requirements
  • Provide significant input in key documents such as the policies, Validation Master Plan and the Site Master File, thereby influencing objectives and overall policy of the
  • Prepare reports for senior management and advise on strategic needs to ensure continued compliance with all regulatory requirements

Quality Assurance:

  • Support the QA Manager with the maintenance of the Quality Management System, including
  • Change Controls and Corrective Actions and Preventive Actions (CAPAs).
  • Undertake impact / risk assessments and mitigation strategies for Quality Events
  • Support the with self-inspections or audits of external contractors
  • Assist with the revision of the supplier and material release system

Communication:

  • Work closely with the QPs and all staff members, assisting with quality related queries
  • Influence staff, department managers and senior management to gain consensus on proposed projects, resolution of events and improvement initiatives
  • Provide advice to staff and colleagues from other University departments
  • Communicate with regulatory bodies (e.g. MHRA, FDA) where necessary
  • Liaise with external sponsors and report quality issues relating to specific projects

Selection criteria:

Essential

  • A degree in life sciences or extensive biopharmaceutical experience
  • Fully competent and experienced in managing all aspects of validation and qualification processes for early clinical trials
  • Sound knowledge of EU GMP guidelines (Eudralex Volume 4), the Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments, ICH Q9 and Q10 and the ability to interpret these in a non-commercial environment
  • A proactive and creative approach to solving problems
  • Ability to complete jobs to a high standard within tight timelines whilst managing conflicting priorities and staff
  • Excellent organisational skills and a keen eye for detail
  • Proven ability to lead and manage a team and experience of dealing with and influencing people at all levels
  • Able to work flexibly, including overtime as may be required, to meet the business needs
  • Knowledge and experience using Quality Risk management

Desirable

  • Knowledge of regulatory affairs for vaccines and advanced therapy medicinal products (ATMPs)
  • Experience / formal qualification in internal/external auditing Project Management skills Experience writing GMP related documents, e.g. standard operating procedures, policies and protocol

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.