GMP Compliance Specialist: CAPA, Change Control & Training

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

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.