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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Operational Quality Manager / Qualified Person


Reference:SMC3849 Location: Tipperary
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

We’re currently recruiting for an exciting opportunity with a pharmaceutical organization. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
  • Support major investigations, ensuring all product deviations are closed prior to batch release.
  • Reviews and approves Product Quality Reviews.
  • Reviews and approves new and revised master manufacturing records.
  • Participates in cross-functional teams as Quality/Qualified Person representative.
  • Participate in third party/supplier audits, as required.
  • Review annual customer complaints.
  • Participation in any product recall or product defects.
  • Actively contribute to continuous improvement initiatives.
  • Conduct duties in a safe manner and report all safety issues and concerns.
  • Complete all duties as per relevant SOP’s.
  • Review of investigation reports.
  • Review of validation protocols.
  • Review of Quality Documentation as appropriate e.g. Bill of Materials etc.
  • Work with relevant departments to ensure timely closure of Quality Actions / Findings.
  • Provide additional QP support to quality related issues, as required

Education & Experience
  • Must meet the minimum training/education requirements for QP qualification
  • Must have at least 5-7 years’ experience working within a Quality Assurance role
  • Work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA) is highly desirable.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.