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Job Description
Quality Oversight and Direction for New Products and Materials
This is an 11-month contract and a hybrid position that requires quality oversight and direction for the introduction of new products and materials, as well as managing external parties.
- Provide quality oversight and direction for the introduction of new products and materials
- Manage external parties and serve as the point of contact for quality at both the site level and with external inputs
- Coordinate and attend Quality working group meetings
Responsibilities
- Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities
- Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation
- Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, and MES documentation
- Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers
- Maintain the approved supplier management list within the qualified Supplier Management system
- Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions
- Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements
Requirements
- Bachelor's degree or higher in a related Science discipline
- Minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment
- Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices
- Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice)
- Strong report, standards, and policy writing skills
- Experience with equipment and process validation
- Familiarity with sterile filling processes and equipment
- Proficiency in Microsoft Office and job-related computer applications
- Experience or familiarity with Lean Six Sigma methodology