This is an 11 month contract position.
The Compliance Specialist will work with the Integrated Process Team (IPT) compliance group, to maintain all aspects of compliance, within the Vaccine IPT team. This will require a substantial amount of their time engaging and communicating with all team members, within the various areas. The Compliance Specialist will promote a culture of compliance excellence at the facility, using a leadership style of collaboration and coaching.
• 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.
• 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.
• 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.
• Knowledge of and experience in applying Lean Six Sigma and Lean methodologies (e.g. 6S.)
• Compant 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.
• High level of skill in Technical Report writing.
• Demonstrated ability to coach and influence others, within the Vaccine IPT.
• Demonstrated ability to initiate and complete Continuous Improvement initiatives.
• Leads Cross-Functional projects and initiatives, as assigned.
• Demonstrated ability to identify issues and provide possible alternatives and solutions, both individually and working cross-functionally.
• Good Organisation Skills. Ability to manage multiple priorities and to know when to escalate issues for resolution (time management.)
• Proven ability to work as part of a highly motivated team.
• Communication skills, both written and oral, including persuading others.
• Good presentation skills. Advanced PC skills such as Excel, Word, PowerPoint.
• Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
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