Quality Ops Specialist - Biotech Manufacturing

Incyte; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Incyte is seeking an experienced Quality Operations professional to oversee GMP manufacturing quality at our Yverdon-les-Bains facility in Switzerland. You will manage daily QA activities, review batch records, ensure cGMP compliance, and drive CAPA and continuous improvement across manufacturing areas.

The role requires a relevant science degree, a minimum of 3 years in pharma Quality Operations, strong knowledge of cGMPs and regulatory expectations, and fluent French with English as a plus.

Qualifikationen

• Academic degree in natural or applied sciences (Pharmacy, chemistry, Biotechnology, engineering).
• Minimum 3 years' experience in Quality Operations for pharmaceuticals at manufacturing sites.
• Thorough knowledge of cGMP and international regulatory requirements.
• Understanding of Biotech processes.
• Experience dealing with international inspections.
• Strong analytical and problem-solving skills.
• Good verbal and written communication skills with a structured communication style.
• Compliance-focused; internal auditor qualifications are an asset.
• Fluent in French (written and spoken) and ideally good level in English.

Aufgaben

• Manage day-to-day quality oversight of USP and DSP manufacturing, washing area, and media/buffer solutions preparation activities.
• Perform Batch Record reviews within defined timelines and recommend batch disposition.
• Review and approve manufacturing SOPs to ensure process efficiency and regulatory compliance.
• Ensure compliance of manufacturing activities with cGMPs and approved procedures.
• Ensure compliance of manufacturing documentation management (logbooks, batch records, FORMs).
• Review and approve Master Batch Records for manufacturing.
• Review and approve deviations and investigations; escalate major/critical issues.
• Recommend and approve CAPA plans and ensure timely implementation.
• Ensure compliance regarding materials management in production (traceability, identification).
• Review, assess and approve changes in area of responsibility; contribute to risk assessments.
• Contribute to continuous improvement initiatives in area of responsibility.
• Perform GMP tours (GEMBA) and track action implementation.
• Represent QA in manufacturing routine operational meetings.
• Foster compliant and right-first-time operations.
• Collaborate with manufacturing to prevent issues and manage unexpected events.
• Promote understanding and application of cGMPs by BioPlant employees.
• Partner with internal stakeholders for efficient collaboration.
• Interpret GMP and regulatory requirements and ensure implementation as applicable.

Kenntnisse

Quality operations

cGMP knowledge

Regulatory inspections

Biotech processes

Analytical thinking

Problem solving

Communication skills

French (written & spoken)

English language

Ausbildung

Bachelor's degree in natural or applied sciences (Pharmacy, chemistry, Biotechnology, engineering)

Internal auditor qualification

Jobbeschreibung

Incyte is seeking an experienced Quality Operations professional to oversee GMP manufacturing quality at our Yverdon-les-Bains facility in Switzerland. You will manage daily QA activities, review batch records, ensure cGMP compliance, and drive CAPA and continuous improvement across manufacturing areas.

The role requires a relevant science degree, a minimum of 3 years in pharma Quality Operations, strong knowledge of cGMPs and regulatory expectations, and fluent French with English as a plus.