Job Title: Operations Compliance Specialist
The Operational Compliance Specialist will work with the compliance group to maintaining all aspects of compliance within team. This includes GMP& EHS compliance. 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 Senior Compliance Specialist helps to molds the culture to one that supports a High Performance Organisation.
- Supports the compliance plan and quality metrics generation
- Complete review and approval of documentation
- Leads walk down and support audits
- Participate in the preparation for and hosting of regulatory and customer audits
- GMP training delivery to 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
- 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 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, Technical. Degree in (Science/Engineering)
For a confidential discussion and more information on the role, please contact Eloisa Ruiz on 021 4809118 or email firstname.lastname@example.org