A Compliance Specialist is required by Careerwise recruitment to work with our Limerick based biotech client…12-month contract position.
Role of this position
- Completes investigations of technical deviations for department issues of non-compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
- Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
- Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
- Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documetation, etc. to assess for compliance with established quality standards, policies and procedures.
- Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established quality standards, policies and procedures.
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
- Strong interpersonal, written, presentation, communication and investigation skills with the ability to engage witha diverse range of individuals across all levels of the organization.
- BA/BS in Engineering/Science discipline with 2+ years experience working in a cGMP
N.B. It is essential that you hold a valid working visa for Ireland
Please call Michael O'Connor today for further information on 091-452410 or email firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)