QUALITY COMPLIANCE SPECIALIST required by CareerWise Recruitment for our LIMERICK based client.
The Quality Compliance Specialist will support the work of our clients Industrial Operations and Product Supply (IOPS) site through the use of quality risk management (QRM) principles and techniques. The scope may also include collaboration with other IOPS Sites, partners, CMOs and their respective programs.
This is a permanent full-time opportunity with an attractive salary and benefits package on offer for the right candidate.
Role of this position
- Ensuring compliance with all aspects of the QRM program.
- Provide advice on all QRM matters within the IOPS organization.
- Facilitate risk assessments.
- Responsible for review and approval of QRM documentation.
- Administration and oversight activities for the site QRM quality system.
- Review procedures, policies and other instructional documents relating to QRM to ensure compliance with company policy and local and international regulatory requirements.
- Provision of monitoring and trending metrics associated with QRM.
- Participates in regulatory and customer audits.
- Collaborates with functional departments to resolve issues and maintain compliance
- Identify gaps in systems and works with management to develop feasible plans for correction
- Coordinate with IOPs QRM team to ensure consistency of execution and documentation across IOPs sites.
- Third level qualification (Ireland) or B.S. (US) in a scientific discipline or related field.
- 3+ years of relevant work experience within the pharmaceutical or biopharmaceutical or related industry.
- Experience in the pharmaceutical/medical device/biotechnology industry with proven experience in leading cross functional teams preferred.
- Good working knowledge of electronic Quality Management Systems and associated metric generation preferred.
- Proficient at report generation using Excel and other MS Office applications.
Please call Michelle Galvin today for further information on 091 373 938 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)