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Pharmaceutical Quality Manager

Job description

Would you like to be part of a new Pharmaceutical Production Unit that would support the Pharmaceutical Quality Systems, Quality Control, and Quality Operations?

YOU will develop and support the departmental goals and objectives, lead the governance of all Quality Systems and Operations metrics for the Pharmaceutical Production unit.

Job Responsibilities

  • Assist in ensuring compliance with requirements of cGMP.
  • Ensure processes and controls are in place as required for the disposition of the finished product.
  • Maintain inspection readiness while ensuring coordination of the Pharmaceutical Production Unit Self-Inspection Program with timely completion of audits and ensuring actions.
  • Assist with troubleshooting as necessary and facilitate appropriate escalations, support root cause analysis, product impact assessments, and CAPA’s for quality events.
  • Maintain QA Document Control for the Pharmaceutical Production Unit and Quality Systems while managing CAPA/Complaints.
  • People management of direct reports for the Quality Assurance team and Quality Systems Associates and Specialist Pharmaceutical Production Unit.
  • Provide leadership and development to the organisation.
  • Assist the QA Director in developing strategies for the Quality function.
  • Control budgets and spending and ensure compliance with financial requirements.

 

Job Requirements

  • Level 8 in a relevant Science discipline.
  • Experience in drug manufacturing, medical devices, or biologics in QA, QC, or Quality Engineering.
  • Experience in Quality Management.
  • External Audit facilitation.
  • cGMP, Notified Body, HPRA, FDA Regulations.

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

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