QA Compliance Officer

Galway

Basic Summary:

To assist in the process of maintaining compliance to Product Licences/ Marketing authorisations for Realoch Pharma

 

Key Responsibilities

  • Conduct Routine Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may
  • Set up and maintain the Internal Audit schedule and ensure its completion as per
  • Prepare and conduct annual GMP training programme for the
  • Approval of Compliance documents e.g. Deviations, SCARS and CAP
  • Conduct External audits and compile External Audit reports and lead the collation of resp
  • Management and assistance with the site change control
  • Handling of customer
  • Provide technical support to the MAH for New Product Introductions and existing Products.
  • Review/lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
  • Ensure Process transfer is documented and conducted in accordance with Regulatory Standards.
  • Quality review and approval of RMWO’s & RPWO’s for Realoch
  • Provision/Updating of existing Quality Procedures in line with issues as they arise as result of validation in cooperation with the appropriate department.
  • Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality
  • Maintenance of records for the company KPls as per Quality management review requirements.
  • Ensure timely feedback on customer/production queries as appropriate.
  • Preparing product quality review reports for Realoch Pharma.
  • Assist in trouble-shooting product problems.

Any other duties assigned by the Head of Quality

 

Qualifications:

  • Degree in Science discipline or equivalent.
  • Minimum of 3 years Quality Assurance experience within the pharmaceutical industry B.Sc. degree as a minimum requirement.
  • Strong organisational skills / ability to prioritize work
  • Proven track record as a team player.
  • Excellent communication and presentation skills with a hands-on approach
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QA Compliance Officer

Galway