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Senior Quality Assurance Professional
2 weeks ago
Job Overview
We are currently recruiting for a Senior Quality Assurance Professional to support our organization's process development initiatives.
- Provide technical support primarily to new product introductions (NPI) and lifecycle management (LCM) changes.
- Support commercial drug product manufacturing operations with the evaluation of Change Control/NC/CAPA and technology transfer.
- Develop validation plans, process performance qualifications for vial and syringe filling.
- Ensure all aspects of activity within any given process validation adhere to required policies and procedures, including safety and training.
Responsibilities:
- Accountable for the success of product transfer projects from initiation to regulatory approval.
- Provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products.
- Support cross-functional teams at the site to ensure adherence to required policies and procedures.
- Act as the responsible point contact for the transfer project for drug product teams and Global Operations Teams.
Requirements:
- Third-level Bachelor's degree in science, engineering or a relevant quality discipline.
- 5 years' experience in a similar role or Master's degree & 3 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem-solving ability and excellent oral and written communications skills.
