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Validation Specialist

Michael Page Engineering & Manufacturing
Job LocationCaerphilly
EducationNot Mentioned
Salary37,000 - 38,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time Work from home

Job Description

The purpose of the role is to enhance Validation practice and compliance; support improvement to validation system and streamline processes. Identify risk areas and required mitigation to meet regulatory inspections through routine compliance activitiesand specific validation project.Client DetailsThis pharmaceutical manufacturer have been expanding due to considerable investment on their South Wales site. They offer a fantastic collaborative work culture and opportunities to attend training courses and develop your skills. As such, the average lengthof service in the company is 12 years, with the longest service being 30 years.Description

  • Ensure that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities and Analytical Method validation.
  • Maintain and support the updating of Validation Schedules within a team based validation structure.
  • Author or review and approve the development and implementation of Validation Master Plans, protocols, reports and standard operating procedures relevant to Validation. .
  • Schedule and coordinate the review of process and equipment validation and re-validation / periodic review in accordance with the established Company validation policy and associated procedures. Complete validation protocols and reports, and ensure compliancewith all relevant Quality Standards and regulatory requirements.
  • Provide support to global organisation, (e.g. participating in the Validation Community of Practice) as appropriate, relating to validation activities and associated regulatory activities and procedures.
  • Serve as subject matter expert and/or team member to support Quality Investigations, CAPA, customer complaint reports, audit findings, failure investigations and continuous improvement opportunities. Ensure accurate and timely resolution and closure toall issues.
  • Contribute to and perform related training on site with regards to validation lifecycle and compliance.
Profile
  • 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 (2+ years)
Job Offer
  • £38,000
  • 25 days holidays, plus bank holidays
  • Remote working 3 days a week
  • Training and development opportunities - attend training courses/get certification
  • Flexible working practices
  • Discounts on cinemas, gyms etc
  • Early 3:30 finish on Friday
  • Progression opportunities
  • Great company culture
  • On-site parking
  • Opportunity to opt in to private health care scheme

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