quality operations manager for early phase and validation.

• 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

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

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