Our client, a leading pharmaceutical company based in Limerick are currently recruiting for an IT Compliance Analyst/Snr IT Compliance Analyst to join their expanding team. This is a full time, permanent position offering an excellent salary and benefits package.
Main Responsibilities:
- Ensures IOPS IT personnel are operating in compliance with regulations and procedures.
- Assists IOPS IT personnel in interactions with Quality Assurance personnel and the Quality Management System.
- Evaluates, develops and modifies IOPS IT Policies and Standard Operating Procedures to meet regulatory and corporate requirements and obligations.
- Tracks and reports on IOPS IT Quality metrics.
- Works closely with QA Validation to ensure IOPS IT systems are validated and maintained in a validated state.
- Represents IOPS IT or assists IOPS IT Subject Matter Experts (SMEs) during internal and external audits.
- Ensures IT operational controls are in place and maintained throughout the system lifecycle (e.g. periodic reviews, disaster recovery testing, performance monitoring etc.).
- Tracks and verifies that all IT Quality instance activities are completed in a timely manner.
- Champions Data Integrity for all IT systems.
- Represents IOPS IT at NOE/Deviation/Event meetings.
- Supports IOPS IT personnel in writing/responding to deviations/CAPA’s/Change Controls and other quality instances.
- Assists IOPS IT personnel in participating in and successfully navigating through the Quality Management Processes.
- Take ownership for technical writing of IOPS IT deviations/CAPA’s/Change Controls and other quality instances.
- Ensures IOPS IT training is adequate and current.
- Presents and reports IOPT IT Quality Metrics (at departmental, site and cross-site meetings).
Education and Experience:
- BS/BA in related field required.
- Analyst – Minimum of 2 years of relevant experience in the pharmaceutical or biotechnology industry preferred.
- Senior – Minimum of 5 years of relevant experience in the pharmaceutical or biotechnology industry preferred.
- Quality Assurance (QA) experience strongly desired.
- Will substitute relevant industry experience for educational requirement
Interested candidates just apply online with their updated CV. For more information, please give us a call for a confidential discussion.
All applicants must be eligible to work in Ireland
