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Vacancy Details

Quality

105315 - R&D Quality Specialist - Mayo

Contract Type: Permanent
Sector:
Location: Mayo
Date: 2/10/2019
Job Reference: 105315
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

R&D Quality Specialist - Mayo - 105315

R&D Quality Specialist / Design Assurance Mayo


Our client, a medical device company in Mayo are currently looking to recruit a R&D Quality Specialist / Design Assurance Engineer for their site.

Role Summary
The R&D Quality Specialist will provide day to day assistance for Clinical Trial Supplies QA activities
ensuring assigned tasks are performed in a timely manner to meet Clinical supply requirements.

The R&D Quality Specialist is involved in the review /and or approval of elements of the quality system for Global
Clinical Supplies Westport including:
• Deviation management
• Change Control Program
• Self-Inspection
• Complaints Management
• Preparation and presentation of Monthly Metrics and Quality Management Reviews
• Preparation and coordination of Annual Mock Recall
• Review of semi-finished batch paperwork
• Review of Clinical Packaging batch records (pre and post approvals)
• Receipt and Release of Clinical Trial components
• Label Design Approvals
• Item Master Approvals
• Managing storage of batch documentation for Global Clinical Supplies Westport
• Management of the Temperature Excursion Process
• Management of Product Specification Files
The R&D Quality Specialist is accountable for their individual areas of responsibility within the company Pharmaceuticals Ireland 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. In association with the Quality Manager 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.

KEY/ACCOUNTABILITIES:

This is a list of Core Duties and must not be taken as a definitive list. You may be asked form time to time to undertake other duties, either in or out of your area of responsibility
1) People
• Maintain strong relationships with management and colleagues in the Global Clinical Supplies Departments at Westport and Sunrise and with Clinical personnel at Marlow. Articulate the necessary requirements in a clear, concise and persuasive manner.

2) Strategic
• Work with the Quality Manager on the delivery of the company quality plan and global regulatory requirements for the site
• Manage quality requirements for process changes and new clinical studies as deemed necessary
• Ensure effective recording, analysis and reporting of KPI’s 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.

3) Management
• 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

4) Administration / Meetings
• Coordinate GTW Management for area of responsibility
• Preparation and review of semi-finished batch paperwork
• Review of Clinical Packaging batch records (pre and post approval)
• Label Approvals
• Item Master Approvals
• Receipt and release of Clinical Trial components
• Coral Review and Approval of assigned documentation as deemed necessary
• Coordinate GCS quality monthly meetings for assessment of quality system performance
• Assist in the preparation and management of site MOH and customer inspections
• Management of Temperature Excursion Process
• Management of Product Specification Files
• Management of Annual Mock Recall
• Review and approval of GTW records and associated documentation
• Complete assigned internal and external audits
• Attend all routine meetings as required. For example: Daily team meetings, metrics meetings, Quality Management Review, Study Planning meetings, GTW meetings


KEY REQUIREMENTS
• Proven track record in a quality discipline in the Pharm/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.
• High level of self-integrity and ethical conduct

Behaviours/Value:
• Relationship Building: establishing excellent working relationships with all functions within PDQA.
• 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.
• Adaptability; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
• Passion for results: - Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
• Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.

Other requirement (i.e travel)
• Undertake any training or travel that the role may require, including the completion of quality inspections of third party facilities as required.



For further information on this R&D Quality Specialist role in Mayo please contact Bimi on 086 8395533 / bimi@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

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