-
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.
Key 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:
- A Bachelor's degree or higher in a related Science discipline is preferred.
- A 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) is preferred.
- 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 is desired.
Skills:
- Quality
- NPI
- GMP
- Equipment Validation