PROJECT MANAGER (POWDERS)
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Job Reference Number |
13517133 |
Client ID: |
RI/26779AA |
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Posted On: |
Jun 29 2009 |
Location: |
SLIGO |
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Job Type: |
Permanent
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Salary: |
SEE DESCRIPTION |
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Senior Quality Assurance Project Manager The Irish Third Party Manufacturing Organization is responsible for contract manufacturing of my clients products in four countries. The principle responsibility is to ensure compliance of products manufactured at those facilities. The initial focus of the Snr QA Project Manager will be to support powder production at the Denmark and New Zealand facilities in addition to Asia.
This role will also be responsible for assessing, establishing and improving operations as required to maintain optimum performance and adherence to 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.
This position will independently interface with affiliates and TPM's. Success will depend on leadership in identifying and correcting quality issues through effective communication, and strong interpersonal and presentation skills. Issues will typically involve GMP's, formulation, process control, fitness for use criteria for risk assessment using strong decision-making and problem solving skills.
The new candidate will work with other Senior QA Project Managers and large organizations. An important aspect of the role will be about managing relationships and responsibility for the manufacture of some products from initial stages to others that are up and running. The successful applicant will report to the QA Director.
Key Responsibilities will include some of the following:
- 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 Approved suppliers list; Raw materials and packaging materials acceptance and specifications & Manufacturing directions, work orders and bill of materials, SOP's
- Facilitate complaint follow up, tracking, complaint communication and identification of preventive actions and resolution
- Facilitate Third party manufacture preparation for Division and Corporate audits and management of audit corrective action plans
- Provide training as required for my client'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 for this role will include:
- Bachelor's Degree in a relevant biological or technical discipline is required (Chemistry, Microbiology, Food Science, Engineering).
- Masters degree in science or business is preferred, but not required
- Seven to ten years in a regulated nutritional food-manufacturing environment, preferably pediatric and medical nutrition products, in a Quality, R&D, Operations function and good knowledge of food cGMP and nutritional regulations is necessary
- Three to five years project management experience
- Success will depend on good problem solving abilities and knowledge in nutritional manufacturing controls and quality system
- Experience establishing microbiological protocols in a manufacturing setting would be highly desirable.
We have worked with this client for over three years to great success and remain as leading provider for their recruitment needs. From placing professional candidates, we are fortunate to provide candidates interested in current positions with excellent company information and interview preparation. In addition, our relationship with the HR and Recruitment team has helped the successful placement of candidates greatly.
Ormonde Recruitment Contact Details:
Ormonde Recruitment ~ Recruitment for medical device & pharmaceutical personnel across Ireland
Aoife O Neill Recruitment Consultant, Ormonde Recruitment, No.1 The Spires, Dean Street, Kilkenny. Tel: +353 56 7786111. www.ormonderecruitment.ie
If this role does not match your skill set, please speak to us or visit our website to view other roles within the medical device / pharmaceutical industry - www.ormonderecruitment.ie
Ormonde Recruitment is a professional body where no CV or details will be submitted to any potential client without prior knowledge, discussion and consent from every candidate.