Description
IT Quality Manager - Cork, Ireland - Contract
My client a top pharmaceuticals company is currently looking to recruit an IT Quality Manager to join its team in Cork, Ireland on a contract basis. The main focus on the IT Quality Manager role is to ensure compliance with all external and internal regulations and policies in relation to the validation of computerised systems.
The IT Quality Manager will also be responsible for the following:
- Ensure all computerised systems are validated and managed in a compliant manner, as per company Procedure SOP-: Computerised System Validation
- Ownership of the AIT quality system encompassing SOPs, system validation and AIT training.
- Oversight of all AIT quality related activities including, deviations, investigations and CAPAs.
- Represent AIT in internal and external inspections; manage the AIT preparation for inspections and follow-up to AIT related observations.
- Prepare, review and approve life cycle documentation for computerised systems, to ensure consistency with quality standards and quality deliverables.
- Coordinate documentation, testing and change management activities to ensure compliance with business and regulatory needs.
- The AIT liaison with the two QA departments on site, a key stakeholder for the site Computer Validation Committee.
- Maintain the CSV Validation Master Plan and the Inventory of GxP Computerised Systems.
- Single Point of Contact for AIT in relation to Document Management.
- AIT change coordinator for changes raised in the change management tool - Remedy on Demand.
- AIT representative for the implementation of global SOPs.
- Manage the AIT training plan, identify training requirements and ensure training completion.
- Review and approve AIT related SOPs, Forms and Work Procedures.
- Responsible for the updating and approval of local procedures to comply with the project (an IT security improvement initiative).
Key skills for the IT Quality Manager include:
- A degree in a scientific discipline such as Information Technology and/or relevant business education is highly desirable
- Group leadership experience and a good understanding and knowledge of business processes in the global health care industry and/or Pharmaceuticals.
- Experience in IT Quality (preferably in project management/service delivery positions)
- Risk management background with experience in risk management related roles
- Knowledge of general IT, project management and compliance topics.
- Good written and verbal communication and presentation skills
- High level of customer focus with proven problem solving skills
This is a contract role for an IT Quality Manager working for a top company. To apply to the IT Quality Manager please send a CV or call to discuss options.
We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, gender reassignment, marriage and civil partnerships, pregnancy or maternity or age.