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Senior QA GDP Consultant
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Client, Consultant
Projektbeschreibung
Our client is a multinational pharmaceutical and is looking for a QA GDP CONSULTANT. The QA GDP CONSULTANT will help the suppliers of our client to adhere to GMP (GOOD MAUFACTURING PRACTICES) and GDP (GOOD DISTRIBUTION PRACTICES).
Location: Walloon Brabant
Duration: 3 months
Scope of work:
Our client is collaborating with several partners-distributors among which in the Gulf region. The designated partner in the Gulf Region will be responsible for the distribution of room temperature and cold chain products in the region. This partner subcontracts with other partners in the region. Regulations require that distribution partners adhere to a quality system (general procedures, storage facilities, complaints management, etc). Therefore our client wishes to appeal to a Senior GDP Specialist who will collaborate with the partner in the Gulf to quickly develop a quality system.
Mission responsibilities:
- Helping and coaching a distribution partner to build a robust quality system for outsourced warehousing and distribution activities (including cold chain activities) that will meet UCB, cGMP, and GDP requirements. This may include writing, reviewing, and approving SOPs.
- Negotiating quality agreements with partners
- Establish direction, develop and drive improvement on distribution & logistics GDP compliance at affiliates and distribution partners in collaboration with key global and local QA sites/stakeholders.
Skills and requirements :
- Fluency in English
- Hands-on mentality
- Ability to negotiate and influence, in particular people who do not have direct authority in the matter
- Analytical mindset (analyse problems and investigate)
- Open to discussion
- Experience in project management
- Experience in partner coaching/supplier management
- Experience in good distribution practice
- Experience in cold chain activities is nice to have
- Experience in CMO's is nice to have
- Total experience: 5-10 years
KEYWORDS: CMO, GDP, GMP, GOOD DISTRIBUTION PRACTICES, GOOD MANUFACTURING PRACTICES, COLD CHAIN, QA, QUALITY ASSURANCE, ASSURANCE QUALITÉ, BPF, BPD
Location: Walloon Brabant
Duration: 3 months
Scope of work:
Our client is collaborating with several partners-distributors among which in the Gulf region. The designated partner in the Gulf Region will be responsible for the distribution of room temperature and cold chain products in the region. This partner subcontracts with other partners in the region. Regulations require that distribution partners adhere to a quality system (general procedures, storage facilities, complaints management, etc). Therefore our client wishes to appeal to a Senior GDP Specialist who will collaborate with the partner in the Gulf to quickly develop a quality system.
Mission responsibilities:
- Helping and coaching a distribution partner to build a robust quality system for outsourced warehousing and distribution activities (including cold chain activities) that will meet UCB, cGMP, and GDP requirements. This may include writing, reviewing, and approving SOPs.
- Negotiating quality agreements with partners
- Establish direction, develop and drive improvement on distribution & logistics GDP compliance at affiliates and distribution partners in collaboration with key global and local QA sites/stakeholders.
Skills and requirements :
- Fluency in English
- Hands-on mentality
- Ability to negotiate and influence, in particular people who do not have direct authority in the matter
- Analytical mindset (analyse problems and investigate)
- Open to discussion
- Experience in project management
- Experience in partner coaching/supplier management
- Experience in good distribution practice
- Experience in cold chain activities is nice to have
- Experience in CMO's is nice to have
- Total experience: 5-10 years
KEYWORDS: CMO, GDP, GMP, GOOD DISTRIBUTION PRACTICES, GOOD MANUFACTURING PRACTICES, COLD CHAIN, QA, QUALITY ASSURANCE, ASSURANCE QUALITÉ, BPF, BPD
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Organisation/Management