Quality operations manager for early phase and validation

☞ Randstad Professionals Belgium

看过: 190

更新日: 16-11-2025

位置: Braine-l’Alleud Walloon Brabant

类别: 科学

行业: Pharmaceutical Manufacturing

水平: Associate

工作类型: Full-time

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工作内容

Quality operations manager for early phase and validation

Introduction

Interested ? Don’t hesitate to contact me: julie.licoppe@professionals.randstad.be

Organisation/Department

Our client is a laboratory that is part of an international group.

Job description

Nature & scope:

The primary goal of this function is to be the QA referent for Early Phase and Validation products and to perform activities of the QA Operation department.

Major accountabilities:

As a QA referent for products in clinical phases (GMP production) and validation, the major accountabilities include to:

  • Be the quality point of contact for customers and participate in the project team meetings
  • Manage customer requests, complaints, recalls and audits and organize the follow-up of findings
  • Manage and approve change controls, CAPAs & deviations linked to the products and inform management in case of any major quality or regulatory issue
  • Review and approve the documentation linked to the projects / products (MBR, analytical documentation, quality agreements, process validation, protocols and reports…)

As a member of the QA operation team, the function also includes:

  • Write, review and approve documentation related to quality activities
  • Be the QA operations referent for projects in clinical phases (GMP production) and validation, provide quality support to other departments and support the continuous quality improvement
  • Work within the Quality and Regulatory team to maintain focused, effective progression in line with department and objectives

Requirements

  • Master’s degree
  • Education or professional experience in pharmaceutical industry, in chemistry
  • Strong knowledge in GMP’s and ICH Q7 is a must
  • Adaptable, cooperative
  • Very sensitive to details and meticulous attitude
  • Team spirit
  • English: reading, writing and speaking
  • Good critical and compromise approach
  • Good communication and organisation skills

Our offer:

Consultancy

We offer an attractive salary with extra-legal advantages:

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car
  • Monthly allowance (80 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible

Our client:

Our client is a laboratory that is part of an international group.

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最后期限: 31-12-2025

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