Job Title/ Position:
Senior QA Engineer (Sterilisation)
Degree in Quality / Technical with emphasis on Medical Device Industry
Minimum 5yrs previous experience in Quality/Validation in Medical Device/Pharma Environment, with knowledge of sterilisation processes – EO and Irradiation.
Duties/ Accountabilities (incl. Deputation):
This involves but is not limited to:
- SME for sterilisation processes for new product introductions (NPI) and maintenance of existing validated sterilisation cycles within the site(s).
- Participation in the new product introductions programme to ensure that they are effectively introduced in accordance with the requirements of ISO 13845 and GMP.
- Participate and assist with other validations that can impact on the sterilisation processes, such as packaging validations for example.
- Work to develop standard company cycle at steriliser.
- Carry out other NPI activities in relation to QA / QE activities as required to support the NPI / R&D processes.
- Participation in the Customer Complaint investigation process and participation in routine failure investigation & process trouble-shooting for all issues reported in cleanrooms 1 & 2.
- Participation in the Plant Corrective Action Programme
- Participation in the Internal Quality Audit Programme
- Work with other Company sites as required to support sterilisation activities as required.
- Participate in the alignment of a “one global” sterilisation procedure for all Company sites.
- Work with the site(s) head of quality to determine the suitability of developing in-house sterilisation processes.
- Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
- Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
- Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
- Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.