STERILITY ASSURANCE COMPLIANCE SPECIALIST

ORGANISATIONAL SITUATION (REPORTING TO): Sterility Assurance Manager

PURPOSE OF POSITION: The primary purpose of this position is to ensure efficient and cost effective Sterility Assurance compliance. This includes developing, implementing, managing and continually improving Sterility Assurance activities to ensure that it is in compliance with current European and FDA requirements.

MAIN DUTIES AND RESPONSIBILITIES:

Ø To be fully conversant with GMP requirements and changing requirements for site wide European and FDA Sterility Assurance Compliance in a parametric release environment.

Ø To identify, implement and provide guidance on improvement opportunities

Ø Act as Site Sterilisation Person deputy as defined in the Sterilisation Monograph

Ø Break out each segment of Sterility Assurance to interpret, define and optimise global requirements, the data and controls in place to meet these requirements and knowledge opportunities across the site.

Ø Help develop educational resources and optimise Sterility Assurance awareness throughout the site.

Ø To maintain up to date validation master files.

Ø Manage the Thermal Validation Schedule.

Ø Develop and coach department members and the wider community where appropriate

Ø Deputise for the Sterility Assurance Manager as required

Ø Present and defend Sterility Assurance data to auditors.

Ø Review relevant documentation such as plans, protocols and reports as required and ensure that same are generated and completed in accordance with defined procedures / standards / master plan.

Ø To lead or participate in teams as required completing specific activities.

Ø To liaise with personnel in the wider community to implement improvements and corporate Sterility Assurance policies and activities where appropriate.

Ø Develop and implement a Sterility Assurance Internal Audit System on site.

Ø Provide technical support to operations and quality on routine production issues

Ø To display exemplary behaviours in line with company Values

PRINCIPAL QUALIFICATIONS REQUIRED: Third Level Qualification in Engineering / Science Discipline

PRINCIPAL QUALIFICATIONS DESIRED: Post Graduate Qualification

Key Competencies Required

• Results orientation


• Resilience


• Team Player


• Tact & diplomacy


• Influencing skills


• Systems background


• Strong work ethic


• Flexible approach to work


• Communication skills


• Genuine interest in people


• Highly motivated


• Initiative