12 дней назад
Specialist Compliance DSP (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Specialist Compliance DSP (Biotech) (cGMP/Quality Compliance): Managing deviations, CAPA, change controls, risk assessments, training, and batch record reviews for biotech drug manufacturing with an accent on inspection readiness, quality systems, and manufacturing compliance. Focus on investigating root causes, defining effectiveness checks, supporting health authority inspections, and driving continuous improvement across DSP manufacturing operations.
Location: Yverdon-les-Bains, Switzerland
Company
operates in the pharmaceutical and biotechnology manufacturing sector.
What you will do
- Manage deviations, investigations, assessments, CAPA plans, effectiveness checks, and change controls within required timelines.
- Maintain inspection readiness and act as a subject matter expert during health authority inspections.
- Define and maintain manufacturing quality and operational KPIs and support continuous improvement initiatives.
- Author, review, and approve SOPs, work instructions, and manufacturing support documents.
- Coach and train manufacturing staff on GMP guidelines and department-specific procedures.
- Review executed batch records, support exception reviews, and implement quality compliance initiatives with QA.
Requirements
- Bachelor’s, master’s, or engineering degree in pharmaceutical or biotechnology engineering.
- 3–5 years of relevant biotechnology industry experience in cGMP drug manufacturing and quality.
- Direct experience with FMEA, root cause analysis, and related quality assessment tools.
- Ability to work in a fast-paced, highly regulated environment.
- Fluent French and English required.
- Teamwork-oriented mindset and the ability to coach and support colleagues.
Culture & Benefits
- Work focused on business integrity, ethics, compliance, and legal requirements.
- Mentor and support DSP manufacturing team members while promoting good manufacturing practices.
- Collaborate with QA, manufacturing staff, and process support stakeholders.
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