Compliance Specialist: GMP, CAPA & Change Control

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

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