Specialist Compliance DSP

Incyte Corporation; Yverdon-les-Bains; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Incyte Corporation is seeking a Compliance Specialist to oversee cGMP quality programs, deviation management, CAPA, risk management, change control, training and batch record review within the manufacturing department. The role entails supporting site quality goals, driving continuous improvements, and acting as SME during inspections.

You will develop and maintain KPIs, author SOPs, and mentor DSP manufacturing teams to adhere to GMP standards and company guidelines in a fast-paced, regulated

Qualifikationen

• BSc, MSc or engineering degree in pharma/biotech.
• 3-5 years experience in biotech cGMP drug manufacturing and quality.
• Direct experience in FMEA, root cause analysis, and quality assessment tools.
• Fluent in French and English.
• Ability to work in a fast-paced, highly regulated environment.

Aufgaben

• Ensure systems are ready for inspection at all times.
• Raise, investigate, assess and close deviations within timelines.
• Define and plan CAPA to prevent recurrence and support process improvements.
• Define and plan effectiveness checks for ongoing quality.
• Manage Change Controls as part of compliance or continuous improvement.
• Define and maintain KPIs for the manufacturing support group regarding quality and performance.
• Act as SME during Health Authorities inspections and present risk assessments, deviations, investigations, CCPs and CAPAs.
• Author, review and approve SOPs and manufacturing supporting documents.
• Coach and train DSP manufacturing staff on GMP guidelines and SOPs.

Kenntnisse

French language

English language

Quality mindset

Ausbildung

Bachelor/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 RESPONSIBILITIES

• 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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