Quality Assurance Supervisor

Quality Assurance Supervisor

Dublin 22



To complete and support activities within the Quality Department relating to GMP Compliance and raw material/product release. To provide Quality support for the manufacturing operations

To act as delegate for all activities within the Incoming Quality Department relating to GMP Compliance and raw material release.



The Role:



Daily briefing on Quality batch review/approval

Provide quality performance information as required

Ensure regular Quality interaction with other Departments

Ensure regular Quality interaction with the sister sites on supplier complaints (back up for the Incoming testing Lab)

Weekly briefing on Supplier complaints 'progress (back up for the Incoming testing Lab)

Supervision of quality technician team

Material release - supervise all laboratory activities for testing of raw materials and ID testing finished product

Quality approval of ID testing results for finished product

Oversight of all activities related to the testing of raw materials and ID testing FP laboratory equipment calibration

Supervision of sampling of raw materials/packaging for quality testing

Supervise all quality in-process control activities including vial defect inspection

Quality batch documentation review and control

Material status assignment

Responsible for customer complaint investigation

Support product recall activities

Generation of annual product quality reviews

Support the process change control system

Support the quality audit/inspection programmes

Process/product/system improvement projects

Drive and oversee process/product/OOS investigations

Provide information to Regulatory Affairs as required

Training of new Quality personnel

Review and Approval of Batch records and SOPs

GMP implementation and site-wide Quality Awareness.

Facilitate Inspections by third parties, e.g. HPRA, FDA, customers, etc.

Responsible for follow up corrective actions identified through the Deviation system.

Liaise with other Department representatives to promote improvements in GMP and Quality standards.

Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.

Participating in the Self inspection program

Follow up on the suppliers' investigation reports from the sister sites and closure of records (back up for the Incoming testing Lab)



Requirements

· Supervisory experience in a quality or manufacturing setting

· Competence in Microsoft packages specifically word, excel and PowerPoint and in SAP

· Strong Technical Writing ability

· Ability to handle multiple projects and deadlines

· Proficiency in communicating and collaborating at all levels of the organisation

· Demonstrated problem solving skills

· Demonstrated project management skills

· Strong Decision Making skills

· B.Sc. or equivalent in chemistry, biochemistry, pharmaceutical science, or related field.

· 5 years progressive experience as individual contributor



Desirable Requirements: M.Sc qualification and Lead Auditor Certified



Contact Ann Marie Corcoran for more information