Specialist Compliance DSP

Incyte; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Incyte in Switzerland (Waadt region) seeks a Compliance Specialist to oversee cGMP manufacturing quality topics, including deviation management, CAPA, risk management, change control, training, and batch record review.

The role includes acting as SME during authorities inspections, developing KPI dashboards, authoring SOPs, mentoring DSP teams, and driving continuous improvement with QA. Fluent in French and English; requires a pharma/biotech degree and 3–5 years in a regulated biotech setting.

Qualifikationen

• Degree in pharma/biotech engineering or equivalent required.
• Direct experience in cGMP drug manufacturing and quality.
• Strong experience with FMEA and root cause analysis.
• Proficiency in quality assurance tools and methods.
• Fluent in French and English; good collaboration skills.
• Experience in fast-paced regulated manufacturing environments.

Aufgaben

• Ensure systems are ready for inspection at all times.
• Raise, investigate, assess and close deviations within timelines.
• Define and plan CAPA to avoid recurrence and improve processes.
• Define and plan effectiveness checks.
• Manage Change Controls to resolve compliance and drive improvements.
• Define and maintain KPIs for manufacturing quality and performance.
• Act as SME during health authorities inspections; present risks, deviations, investigations, CCPs and CAPAs.
• Develop and maintain business KPIs and support continuous improvement.
• Author, review and approve SOPs and manufacturing documents.
• Mentor DSP manufacturing team; enforce GMP practices.
• Coach and train manufacturing staff to GMP guidelines and SOPs.
• Provide cross-department training on quality concepts.
• Proactively propose problem resolution for processes and equipment.
• Review and support execution of batch records (exception reviews).
• Implement quality compliance initiatives with QA support.
• Coach and support team members on quality matters.
• Promote a culture of integrity and compliance with company policies.
• Delegate to DSP Manager / Process Support Manager.

Kenntnisse

cGMP experience

FMEA

Root cause analysis

Quality assessment tools

French and English fluency

Teamwork

Compliance mindset

Ausbildung

BSc/Master/Engineering in Pharma/Biotech

Jobbeschreibung

Overview

SUMMARY

The compliance specialist is responsible for managing compliance related topics including deviation management, CAPA, risk management, change control, training and batch record review.

The compliancespecialist will support cGMP and site quality compliance goals within manufacturing department. He/She will also manage continuous improvements and efficiency projects.

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 DSP manufacturing team members and lead by example to ensure integration of good manufacturing practices
• 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 DSP equipment
• Review and support the review of executed batch report (exception review)
• 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: DSP Manager / Process Support Manager

Requirements

• BSc, Master or Engineering Degree in Pharma/Biotech engineering
• Relevant experience in biotech industry related to cGMP drug manufacturing and quality.
• Direct experience in FMEA, root cause analysis, and associated quality assessment tools
• Typically minimum 3-5 years of experience
• Ability to work in a fast paced – high regulated environment
• French and English (Fluent)
• Team work oriented mindset

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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