The Compliance Specialist will promote a culture of compliance excellence at the facility, using a leadership style of collaboration and coaching.
Summary:
Leads GEMBA walkdowns frequently, ensuring that areas are always audit ready. Through collaborative and open dialogue, coach area owners in the compliance requirements. Assist them in formulating corrective plans where required, putting a process in place, confirming that actions are addressed.
Ensures the highest Quality, Compliance and Safety standards. The Compliance Specialist helps to mold the culture to one that supports a High Performance Organisation.
Responsibilities:
Supports the Vaccine IPT compliance plan and generation of quality metrics
Complete review and approval of IPT documentation
Tracking and directing follow-up activities, to correct any non-conformity
Leads GEMBA walk downs
Participate in the preparation and hosting of regulatory and customer audits
GMP training delivery to IPT personnel
Investigation of Minor Deviations
Provide Compliance guidance to Operating procedures
Review Deviation Trends and identify effective CAPA's, where necessary
Member of the site Permanent Inspection Readiness (PIR) team, ensuring that the Vaccine IPT 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
Optimises existing operations and practices with a focus on continuous improvement initiatives.
Job Experience:
Knowledge of and experience in applying Lean Six Sigma and Lean methodologies (e.g. 6S)
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
Qualifications:
3rd Level Degree in Science/Engineering
5 years' experience in Biopharmaceutical or Pharmaceutical industry
>2 years' experience in a Quality / Operations role
Demonstrated technical knowledge and experience in compliance (GMP, Engineering, Technical)
Desirable: Evidence of Continuous Professional Development
