Expert Compliance Manufacturing

Incyte; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Incyte is seeking a Compliance & Training Expert to manage deviation handling, CAPA, risk management, change control and staff training within a GMP manufacturing context.

The role supports operations, continuous improvement and ensures adherence to quality standards across the MFG staff, acting as SME during inspections and mentoring the team in GMP practices.

Qualifikationen

• Experience in biotech with cGMP drug manufacturing and process validation.
• Direct exposure to FMEA, RCA and quality assessment tools.
• Proven leadership and team management in a fast regulated environment.

Aufgaben

• Ensure systems are inspection-ready at all times.
• Raise, investigate, assess and close deviations within timelines.
• Plan CAPA to prevent recurrence and drive process improvement.
• Define and monitor effectiveness checks and KPI for the manufacturing support group.
• Author, review and approve SOPs and work instructions.
• Coach manufacturing staff in GMP guidelines and SOP adherence.
• Act as SME during health authorities inspections and support QA initiatives.

Kenntnisse

FMEA

Root Cause Analysis

Quality Tools

Leadership

Team Management

GMP Compliance

Biotech Domain

Ausbildung

BSc / MSc in Pharma/Biotech

Jobbeschreibung

Overview

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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