Compliance Specialist

  • Cork
  • Permanent
  • JO-1901-64182_1548244849

Summary

POSITION RESPONSIBILITIES
The Compliance Specilaist will work with the Integrated Process Team (IPT) compliance group to maintaining all aspects of compliance within the Vacciine IPT team. The leadership style is one of collaboration, coaching . This will require a substantial amount of his/her time within the various areas, engaging and communicating with all team members.
Activities Within Role: The 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
* Provide Compliance guidance to Operating procedure
* Review Deviation trends and identify effectiuve 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.
Qualifications

Requirements
* Degree in (Science/Engineering)
* 5 years' experience in pharmaceutical industry.
* >2 years' experience in operation /Quality role.
* Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical).
* 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, PowerPoint.
* Demonstrate the ability to coach and influence others within the Vaccine IPT

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