Our client, a pharmaceutical company in Mayo is currently looking to recruit a Senior Quality Compliance Specialist for their site.
Compliance analyst will hold responsibility for QA activities in support of all aspects of commercial, clinical and development activities at the site. The Compliance analyst will assist the associate director and Snr manager in the management of key quality system elements including:
- Deviation management;
- Change Control Program,
Inspection Management: (Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management);
Quality metrics & monthly quality system & Senior Management review meetings; (Meeting preparation and coordination of post meeting commitments
Manage regulatory standard/guidance revision assessments:
Coordinate the site quality plan and ensure plan execution:
- Manage compliance initiatives program:
Management of site quality risk management program: (Management of the site QRM improvement plan. Attend risk assessment meetings)
- The Compliance analyst is accountable for their individual areas of responsibility within the quality system.
- The position holder must show the competence to drive forward the quality processes at the site and the skills to ensure that Compliance adds to the greater benefit of the facility.
- The Compliance analyst must represent the quality function for routine commercial activities at the site ensuring quality compliance is upheld across all business units and supporting functions as deemed necessary.
- The position holder will provide the necessary guidance relating to quality activities in support of new product introductions and site strategic projects.
- In association with the associate director and Snr manager the Compliance analyst will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health.
- Proven track record in a quality discipline in the Pharma/Medical Device environment.
- Third level Science qualification
- Clear understanding of working within a regulated environment
- Excellent communication skills
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Proven to be self-directed, self-motivated and ability to prioritise competing priorities
- Undertake any training or travel that the role may require, including the completion of quality inspections of third party contract facilities as required.
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