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Operational Quality Manager/QP | Tipperary

  • Sector: Science & Pharma
  • Contact Email: aisling.lane@collinsmcnicholas.ie
  • Job Ref: 19570

Operational Quality Manager/QP | Tipperary

The Operational Quality Manager/QP plays a key role on site and will sit on the Quality Leadership Team.

Overview of Main Responsibilities (full job description available on request):

  • Manages the batch disposition process to ensure timely release of products.
  • Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
  • Disposition of company products and materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
  • 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 a Quality/Qualified Person representative.
  • Participate in third-party/supplier audits, as required.
  • 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.
  • 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

What the ideal candidate looks like:

  • Must meet the minimum training/education requirements for QP qualification.
  • Must have at least 5-7 years of experience working within a Quality Assurance role.
  • Work experience acting as a Qualified Person, named on a Manufacturing and Importation Authorisation (MIA) is highly desirable.
  • Finished dosage formulation manufacturing experience is a requirement for the role.
  • Outstanding organisational and time-management skills.
  • Ability to leverage/collaborate effectively with internal and external stakeholders.

What you will get in return:

  • Competitive Salary (depending on experience).

For a confidential discussion and more information on the role, please contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

(021) 4320675