Our client, a pharmaceutical company in Mayo is currently looking to recruit an Quality Compliance Specialist for their site.
- A Compliance Professional at the facility will hold responsibility for QA activities in support of all aspects of commercial, clinical and development activities at the site. The Compliance professional will assist the compliance supervisor and manager in the management of key quality system elements including:
- Deviation management;
- Change Control Program,
- Vendor Management (selection and approval; quality agreements, audit schedule),
- 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 professional 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 Professional 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 Compliance Supervisor and manager the Compliance professional 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.
- People 10%
- Maintain strong relationships with management and colleagues in the business units, support functions and the quality site and global functions. Articulate the necessary quality requirements in a clear, concise and persuasive manner.
- Work with the Compliance Supervisor and manager on the delivery of the company quality plan and global regulatory requirements for the site
- Assess quality implications of new regulatory guidance and implement necessary changes
- Manage quality requirements for process changes & new product introductions as deemed necessary
- Ensure effective recording, analysis and reporting of quality KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement.
- Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program.
- Represent the company in Ministries of Health inspections as required
- Provide quality input as required, providing direction on day to day activities as a member of the site quality team.
- Foster an environment of continuous improvements for the Compliance area by identifying and implementing efficiencies and quality improvements.
- Support process changes/ validation projects where Compliance services are required.
- Work with business unit representative and supporting functions to ensure site and global quality metrics are achieved and exceeded each month through the implementation of department process improvements and working with key site vendors to ensure high quality standards are implemented.
- Co-ordinate QMS Management for area of responsibility and site overview
- CORAL: Review and approval of assigned documentation as deemed necessary and the process quality agreements.
- Coordinate site quality monthly meetings for assessment of quality system performance
- Compile quality metrics for business units and support functions
- Compile data and coordinate meeting requirements for the bi-annual senior management review meetings as per regulatory requirements
- Coordinate the review of revisions to regulatory standards/guidance
- Assist in the preparation and management of site MOH and customer inspections
- Management of vendor audit program
- Review and approval of Trackwise records and associated documentation
- Complete assigned internal and external audits
- Management of completion of interventions for media run schedule for the business units
- Coordination of site residual monitoring program.
- Attend all routine meetings as required or arrange an appropriate deputy. For example: Site Project meetings/EH&S Meetings, ANDON Boards/APEX meetings as assigned.
- Ability to independently represent the quality function at project meetings and make sound decisions in support of project needs ensuring quality needs are understood and implemented
- Compliance Supervisor, & team
- QA Manager
- Director QA Operations
- Corporate QA
- Quality management team
- Qualified Persons
- Interactions with all functions external to quality, including operations, logistics, engineering, facilities, laboratories
- Key company vendors through the audit program
- Education and Experience/Knowledge:
- 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
- Relationship Building: establishing excellent working relationships with all functions within the business unit and QA team.
- Communication: excellent communication and presentations skills, both written and oral. Articulate the quality requirements in a clear, concise and persuasive manner.
- Planning & Organising: excellent analytical skills. Ability to plan and schedule.
- Decision Making: identify and understand issues, problems and opportunities whilst providing a viable solution.
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