Senior Compliance Specialist
Our client, a medical device company in Cork are currently looking to recruit a Senior Compliance Specialist for their site.
- The Senior Compliance Specialist helps to moulds the culture to one that supports a High Performance Organisation.
- Supports the Vaccine IPT compliance plan and quality metrics generation
- Complete review and approval of IPT documentation
- Leads walk down and support audits
- Participate in the preparation for and hosting of regulatory and customer audits
- GMP training delivery to IPT personnel
- Investigation of Minor Deviations
- Investigation of EHS Incidents
- Provide Compliance guidance to Operating procedure
- Review Deviation trends and identify effective CAPA's where necessary
- Member of the site PIR team works with the Vaccine IPT to ensure that the department is Permanently Inspection Ready.
- Proactive monitoring of CAPAs to ensure holistic trends are proactively resolved
- Participates in the overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA
- Participates in Quality Risk Management and is an IPT QRM facilitator and QRM Lead.
- 5 years' experience in pharmaceutical industry.
- >3 years' experience in operation /Quality role.
- Demonstrated technical knowledge and experience in compliance (GMP, Eng, and Technical.
- Degree in (Science/Engineering)
- Core Competencies
- MMD and site quality policies, procedures and guidelines
- Relevant GMP standards
- The Quality System
- Site procedures and policies
- Understands key business drivers and uses this knowledge to make decisions and prioritise
- Must possess a high standard of knowledge and skills in the following areas:
- Communication skills both written and oral including persuading others
- Technical report writing
- Time management
- Problem solving skills applied to issue identification and resolution
- Continuous improvement skills:
- Interpersonal Team membership and leading Skills e.g.: Listening, integrating diverse perspectives, adds value to the achievement of team goals.
- Responds to non-standard requests
- Supports cross functional investigations
- Timely decision making.
- Demonstrated initiative and pays attention to detail
- Good presentation skills. Advanced PC skills such as Excel, Word, and PowerPoint.
- Demonstrate the ability to coach and influence others within the Vaccine IPT
- Organisation Skills: Ability to manage multiple priorities and to know when to escalate issues for resolution
- Proven ability to work as part of a highly motivated team member
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