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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Validation Lead


Reference:SCA013693 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Validation Lead
Our client, a global pharma and biotech service provider, are currently recruiting for a Validation Lead to join their team. As Validation Lead you will develop, implement and maintain a validation master plan and execute all activities as it relates to this plan. You will also execute and plan validation activities for new equipment when required. This is a maternity leave contract. The role will be hybrid working with travel to other business sites, hence a full drivers licence is required.

Responsibilities

  • Lead all interactions with regulatory agencies / auditors as they relate to validation
  • Develop validation documentation suite templates for the IQ/ OQ/ PQs along with validation protocols and reports.
  • Design validation studies
  • Develop a validation master plan taking account of core competencies such as risk assessment and change management
  • Critical analysis of validation data and processes
  • Work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GxP regulatory requirements
  • Develop and mentor validation teams and other departments to enable the growth of core validation methodologies
  • Work with the business to investigation deviations as they relate to validation, temperature, or equipment malfunction
  • Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies
  • Coordinate the implementation or scheduling of validation testing with across the group
  • Conduct audits of validation across group entities to ensure compliance with internal or regulatory requirements
  • Direct validation standards to achieve harmonization across the group
  • Communicate with regulatory agencies regarding inspection deficiencies and or validation plans / projects
  • Develop a strategic approach to validation to ensure compliance with GxP regulation based on core validation methodologies
  • Guide and advise on group projects as the subject matter expert on validation
Requirements
  • Third level degree in a science/engineering subject as a minimum
  • Previous validation experience with controlled temperature units is advantageous
  • Good understanding and application of GMP and regulatory requirements
  • Experience of wide range of validations including equipment, cleaning and facilities validation plans
  • People management experience advantageous
  • Excellent interpersonal, verbal and written communication skills
  • Demonstrated ability to lead, direct and influence people
  • Experience in the pharmaceutical wholesaling/distribution arena
  • Strong planning, organisational and time management skills
  • Full drivers licence
For more information contact Sinéad Cullen on +353879500821 or [email protected]