Xelvin | Enterprising technicians

QA TPM Project Manager (9 Month contract)

Date:

21-10-2011

Reference:

1667 

Industry:

Farmaceutische industrie 

Department:

 

Location:

NL Overijssel 

Company

Our client, a US Multinational Pharmaceutical company is seeking to recruit a QA Third Party Manufacturer Project Manager for its nutritional division for a 9 month contract.

The Irish Third Party Manufacture (TPM) Organisation is responsible for contract manufacturing of products globally.
The principle responsibility of this role is to ensure compliance of The Company’s products manufactured at the facility in the Netherlands.
Reporting into the QA Manager TPM, this role is responsible for assessing, establishing and improving operations as required maintaining optimum performance and adherence to The Company’s Nutrition quality standards. Once implementation phase is complete, the role will move to day-to-day management of quality system requirements while also playing a large part in the execution of strategy.
The role can be based in Sligo (Ireland) or in the Netherlands

Function description

• Work with project management on global nutritional project teams as assigned, to identify key quality issues related to design, manufacturing and product start-ups and support product launches in various global markets.
• Work with site QA to identify and implement Quality Systems / GMP improvements, to ensure regulatory compliance.
• Utilize understanding of QA systems and problem solving tools to provide alternative solutions to quality issues.
• Support disposition of product batches, utilizing CAPA tools to facilitate investigations, troubleshoot and resolve quality issues.
• Initiate and review quality documentation, such as:
o Approved suppliers list
o Raw materials and packaging materials acceptance and specifications
o Manufacturing directions, work orders and bill of materials, SOP’s
• Facilitate complaint follow up, tracking, complainant communication and identification of preventive actions and resolution.
• Facilitate TPM preparation for Division and Corporate audits and management of audit corrective action plans.
• Provide training as required for The Company’s Quality systems.
• Coordinate the vendor program at the TPM. Work with suppliers and TPM’s to resolve issues.
• Initiate and facilitate specification reviews/changes as required. Initiate policies, procedures and systems that will ensure vendor program requirements are met.

Requirements

• Bachelor’s degree in a relevant biological or technical discipline is required.
• Master’s degree in science or business is preferred, but not required.
• 7-10 years in a regulated nutritional food-manufacturing environment, preferably paediatric and medical nutrition products, in a Quality, R&D, Operations function and good knowledge of food cGMP and nutritional regulations is necessary.
• 3-5 years project management experience.
• Language fluency in Dutch/German would be highly desirable.
• Role involves significant travel 20 - 50 %

Interested?

Are you interested in this vacancy? Then you can apply directly contact by telephone: Roel Wiersma from office Xelvin Groningen, with the follwing telephone number 050-5494072.