Compliance Specialist West Cork

Kenny Whelan And Associates

Cork

Kenny-Whelan are hiring a Compliance Specialist to work in the Vaccines group on our clients Biopharma site in West Cork. Contact Jenn Dinan on 0214665408 and email your CV to jdinan@kenny-whelan.ie. 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, Skills & Experience Required Qualifications. 2 years’ experience in operation /Quality role. Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical. Degree in (Science/Engineering. Core Competencies. Knowledge: 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. Skills: 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, PowerPoint. Demonbstrate 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 abiloity to work as part of a highly motivated team member. All applications will be treated with the strictest of confidence Contact Jenn Dinan on 0214665408 and email jdinan@kenny-whelan.ie. This job originally appeared on RecruitIreland.com.

1786 days ago