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Validation Lead

Employer
Hobson Prior
Location
England, Stevenage, Hertfordshire
Salary
£50000 - £60000 per annum
Start date
21 May 2021
Closing date
15 Jun 2021

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Hobson Prior are looking for a Validation Lead to support all site functions with regards to facility, equipment, process, analytical method and computerised systems validation activities. You will have the opportunity to join an innovative clinical-stage immunotherapy organisation.

Please note that to be considered for this role you must have the right to work in this location.


Job Responsibilities
:

  • Leading compliance with Validation Master Plan and QMS policies and standard operating procedures (SOPs).
  • To be producing validation plans, protocols and reports.
  • Project managing and executing validation exercises.
  • Supporting QMS processes and taking part as required in supplier qualifications, deviation investigations, CAPA and change control implementations.
  • To be supervising equipment maintenance and calibration schedules.
  • You will be organising validation and technology transfer activities with sister sites, suppliers and third parties.
  • To be liaising with Production, Quality Control, Quality Assurance, Regulatory Affairs and Supply Chain providing as necessary to support compliance with GMP and regulatory requirements.
  • Supporting Quality Assurance team with general QA activities where required.
  • To be deliver training to site personnel.
  • You will execute risk assessments and impact assessments.
  • Confirming compliance and qualification of systems with respect to Data Integrity guidelines.

Key Skills:

  • Good interpersonal, verbal and written communication skills.

Requirements:

  • Bachelor's degree in the biological/pharmaceutical sciences or pharmaceutical/biological process engineering discipline.
  • At least 5 years GMP experience in validation related roles within a biotech, sterile products or biologics manufacturing environment.
  • Experience spanning facility, equipment, process, analytical method and computerized system validation.
  • Experience of implementing and qualifying data integrity controls form computerized systems and equipment.
  • Knowledge of Quality Management System elements and experience in maintaining and improving systems supporting the QMS.
  • Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU, ISPE, ISO, GAMP and ICH standards.
  • Experience with application of risk management practises and problem-solving techniques e.g. conducting risk assessments, impact assessments, FMEAs etc.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Find Us
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom
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