Qualification Incoming Materials and Suppliers Specialist 93161

you are ready for your next challenge in pharma industry ?

you have a good knowledge of regulatory and quality system requirements for the suppliers ?

take a look at our job description and feel free to contact me :

julie.licoppe@professionals.randstad.be

• 
  educational background as Pharmacist, PhD Degree in a relevant scientific, quality or technical discipline.be able to understand main regulatory constraints and main vaccines manufacturing processes.

• relevant to position demands to ensure basic understanding of production processes and to be an effective member of the QSIM.

Related Experience required

• knowledge of regulatory and quality system requirements and ability for the supplier to comply with standards.
• good verbal and written communications skills in French and English to ensure issues, risks and opportunities are well understood by all parties and that effective actions are put in place.
• ability to function efficiently in a matrix organization in order to ensure effective communication of issues to all impacted sites / functions.
• understand negotiations related to implementation of appropriate regulatory requirements and quality standards.
• experience with Microsoft Office applications and have the ability to learn new software applications such as SAP.

Other Mission-Related Skills/Background

• understand the need to function across multiple cultures and geographic boundaries.
• understanding of technologies used within the material supply base.
• understanding of cGMP regulatory requirements and standards.

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.

our client – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer

mission purpose

• manage the qualification of incoming materials and suppliers.
• manage a collaboration with the suppliers in order to ensure quality of suppliers, service providers and Incoming materials and to ensure that our client quality requirements and expectations are taken into consideration.
• manage change received from the supplier
• understand and deploy regulatory constraints (GMP, ISO …), as well as internal procedures, related to management of incoming materials
• manage deviation and CAPA, if needed
• give support to the QA validation team, if needed

key responsibilities

• perform and follow material qualifications in partnership with the project team, MSAT, QC, TRD, Belgium manufacturing facilities and suppliers
• communicate suppliers/quality issues to stakeholders through appropriated escalation processes
• understand and manage actions of mitigation if needed

• Understand and manage current regulatory requirements, as well as internal, environment related to

incoming materials.

• Be able to support the team by writing deviation and CAPA
• Support team members on specific activities.
• Experience in QA validation is welcome