Validation Specialist

2022-06-16 15:26:502025-03-10Petrie Recruitment
Job TypePermanent Full Time
AreaCaerphilly, WalesCaerphillyWales
SectorEngineeringScienceQuality
SalaryCirca 37k dependant on experience
Start Date
Advertiserremoteapi
Job RefPR5239
Job Views101
Description
Salary– Circa 37k dependant on experience
 
Contract Type: Permanent
 
Job Elements
  • Enhance Validation practice and compliance; support improvement to validation system; streamline processes.
  • Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects
  • Maintain all validation compliance activities in a timely manner in line with the Site Validation Plan.
  • Work closely with all site departments reliant on validation support to facilitate validation aspects of all projects.
  • Advise and contribute to Process Flow and Risk Assessment activities.
  • Draft Validation Plans, Protocols and Reports when required.
  • Subject matter expert within Investigations, CAPA, Quality Events.
  • Functional expert for Change Request Impact assessments when delegated or in absence of Validation Section Leader.
  • Report validation status to Validation Section Leader.
  • Be aware of updated regulatory guidance and modify site procedures accordingly to maintain compliance.
  • Contribute to the Validation Community of practice when required.
 
The ideal candidate will have:
  • Bachelors/Undergraduate Degree in a science or engineering related discipline (chemistry, biology, process engineering, pharmaceutical or medical technology preferred).  Alternatively, in house or external training in Validation, Quality and Regulatory activities.
  • Previous Validation experience (minimum 5 - 10 years) in Healthcare/Pharmaceutical manufacturing/packing, medical device or biologics industry.
  • Previous team leadership experience (direct or indirect) desirable, operating in a matrix organization.
  • Demonstrated understanding of Quality Assurance, Quality Control and Validation Risk Based Principles
  • Demonstrated computer skills and a working knowledge of basic computer software (Microsoft Office, Excel, Visio etc. preferred)
  • Demonstrated verbal and written communication skills, including the ability to conduct oral presentations
 
 
Petrie Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.
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