Specialist Compliance DSP

Incyte Corporation; Lavamünd; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

Incyte Corporation is seeking a Compliance Specialist responsible for managing compliance topics including deviation management, CAPA, risk management, change control, training and batch record review in a biotech manufacturing setting.

The role supports cGMP and site quality compliance goals within manufacturing, and leads continuous improvements and efficiency projects across the department.

Qualifications

• 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.

Responsibilities

• 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 enable process improvement.
• Define and plan effectiveness checks.
• Manage Change Controls Process for compliance resolution and continuous improvement.
• Define and maintain KPIs for manufacturing support group regarding quality and operational performance.
• Act as SME during Health Authorities inspections by presenting risk assessments, deviations, investigations, CCP and CAPAs.
• Develop and maintain business KPIs and propose/support continuous improvements.
• Author, review and approve SOP/WI or any manufacturing supporting document.
• Mentor DSP manufacturing team and lead by example to ensure GMP integration.
• Coach and train Manufacturing Staff to GMP guidelines and sub-department SOP.

Skills

FMEA

Root cause analysis

Quality assessment tools

Team work

Fast paced environment

French language

English language

Education

BSc/Master/Engineering in Pharma/Biotech

Tools

Gaussian processes

Job description

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.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

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