applications

Sterilisation/Biocompatability Specialist

(Maternity Backfill)

DEPARTMENT: Quality Assurance & Regulatory Affairs

EDUCATION/TRAINING REQUIRED:

· Degree level qualification in Science or Engineering equivalent

· Familiarity with microbiological aspects of GMP regarding sterile medical devices
Experience of conducting GMP audits, internal and relevant external audits; ideally qualified as a lead auditor.

· Knowledge of both the FDA and ISO regulations for medical devices

· Experience in dealing with HVAC systems is desirable.

• Minimum 3 years post qualification experience in a Quality role within a medical device, pharmaceutical, or similar regulated industry.

SKILLS REQUIRED:

· Demonstrated experience in auditing contract sterilization suppliers

· Experience with ETO Sterilization and GAMA.

· Ability to work on own initiative with minimum supervision

· Good interpersonal skills and an ability to deal with all levels of the organization.

RESPONSIBILITIES:

The purpose of this role is to be the company's expert on the application and practice of microbial assurance and biological evaluation programs for medical devices. Additionally this person will act as a support to R&D, manufacturing and quality teams in providing expertise and guidance on microbial assurance in the monitoring of Sterilized medical devices. This role will support efforts to ensure that the company meets all corporate, FDA, Department of Health & Medical Device Directive and European Standards requirements. Duties will include the following:

· Oversee/co-ordinate use of all microbial services, review and develop procedures for all microbial assurance activities.
Co-ordinate and complete biological/biocompatibility testing and evaluations for product ranges as required.

· Work with New Product Development teams and undertake microbial, sterilization validation, and biocompatibility testing of new products as required.

· Carry out regular internal auditing of all Environmental controlled areas, lead ECA Re-certification activities including review and approval of associated documents.
Regularly audit the sterilization subcontractors, contract laboratories and clean room clothing suppliers

· Implement the GMP training programme for environmental controlled areas and other appropriate staff.
Maintain strong knowledge of alternative sterilization technologies for the site that could be applied to products.

· Implement the microbial assurance aspects of the Quality System

· Partner with Cleaning Validation Project Leader to ensure development of robust cleaning validation programme.

For more information on this role please call Eleanor on 021 2300 302 or send your CV to jobs@brunel.ie