Our client a leader in the Pharmaceutical Industry is seeking a Quality Engineer to join their Team in their Sligo Facility on a 9 month temporary contact with a view to a permanent contract.
Job Summary:
To ensure that products manufactured at the site complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements.
To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved. Ensure that all actions comply with current good manufacturing practice.
Key Responsibilities:
Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
Audit the quality system with other personnel where required.
Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions.
Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.
Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports, etc.
Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance.
Ensure implementation and compliance with relevant Regulator requirements.
Assist in the performance of validation activities at the site.
Ensure Quality System documentation is thorough, complete, and compliant.
Ensure compliance with training requirements is maintained.
Review lot records, ensuring documentation is compliant with requirements and completing lot release for shipment.
Inspect incoming products and manage the supplier Quality relationship.
Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
Complete in-process and final release product testing per the relevant approved specifications and procedures.
Where required. Review batch records, ensuring documentation is compliant with requirements.
Complete disposition decision for the batch.
Participate in Risk Management activities as required.
Essential Requirements
Degree in an Engineering, Science, Quality or other discipline.
Desired Requirements
A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
Experience Required
Technical/Business Knowledge
2 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable.
Experience in an injection moulding or tooling environment is desirable.
For a confidential discussion and more information on the role, please contact Emma Daly
emma.daly@collinsmcnicholas.ie
0861041202