Compliance & Training Expert

SUMMARY

The Compliance & Training Expert is responsible for managing compliance related topics including deviation management, CAPA, risk management, change control and training.

He/She will coordinate with Manufacturing Manager complete adherence to GMP rules, training process of the whole MFG staff. During routine manufacturing operation, he/she supports operational activities, continuous improvement and compliance.

DUTIES AND RESPONSABILITIES

• Ensure that the systems are ready for inspection at all time 
• Raise, investigate, assess and close Deviation within timelines
• Define and plan CAPA to avoid recurrence and allow process improvement.
• Define and plan effectiveness check
• Manage Change Controls Process as compliance resolution or for continuous improvement.
• Define and maintain KPI for manufacturing support group regarding quality and operational performance
• Act as SME during Heath Authorities inspection by presenting Risk Aassessment, Deviations, Investigations, CCP and CAPAs
• Develop and maintains business KPI’s and proposes/supports continuous improvements
• Author, review and approve SOP/WI or any manufacturing supporting document
• Act as a mentor to manufacturing team members and lead by example to ensure integration of good manufacturing practices
• Maintain an adequate Training Process and warranty a full adherence within MFG staff 
• Coach and train Manufacturing Staff to GMP guidelines and sub-departement specific SOP
• Provide Training Polyvalence Overview within sub-department
• Proactively propose problem resolution to process and equipment
• Implement quality compliance initiatives in the department in collaboration with QA
• Coach and support other team members for quality compliance matters (such as deviation and changes management)
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
• Delegate to: Process Support Manager

REQUIREMENTS

• BSc, Master or Engineering Degree in Pharma/Biotech engineering
• Relevant experience in biotech industry related to cGMP drug manufacturing, process design, equipment qualification, change control, equipment modification, and process validation
• Direct experience in FMEA, root cause analysis, and associated quality assessment tools
• Typically minimum 5-7 years of experience
• Proven leadership experience managing a team
• Ability to work in a fast paced – high regulated environment
• French and English (Fluent)
• Team work oriented mindset
• Act within compliance and legal requirements as well as within company guidelines

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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