Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Roles & Responsibilities:
- Independently draft and execute complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment.
- Balance competing priorities while ensuring global work is conducted per regulatory requirements and company procedures.
- Serve on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvement.
- Train personnel in quality and validation principles.
- Support Engineering and other departments in the selection, review, acquisition, and upgrade of systems and production equipment.
- Provide technical support in developing user and functional requirements specifications (URS, RA, FRS, DQ) for systems and equipment.
- Act as Lead Validation representative on assigned project teams; communicate new requirements and perform training with Validation team to assure timelines are met for successful project completion and product launches.
- Share quality philosophies throughout Operations and support Production and Engineering.
- Perform all company business in accordance with regulations (EEO, FDA, etc.) and company policies.
- Develop audit responses and complete CAPAs by target due dates; ensure Validation areas are "inspection ready at all times.
- Execute actions required to support Change Control, Deviation, and CAPA on-time closure.
Education & Experience :
- Minimum 6 years GMP validation or similar experience in a GMP manufacturing/production environment.
- Minimum 10 years GMP validation experience in a GMP or regulated manufacturing environment in lieu of a degree.
- At least 3 years leading projects.
- Ability to plan, schedule, organize, prioritize, and coordinate project activities.
- Ability to function in a leadership role and within cross-functional teams.
- Ability to analyze validation and production data to assess compliance with GMP requirements and troubleshoot compliance problems.
- Excellent written and verbal communication skills.
- Strong comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles.
- Strong theoretical and practical knowledge of regulated processes and one technical discipline (e.g., biology).
- Ability to make decisions regarding product acceptability based on documentation.
- Demonstrated ability to work with diverse groups and manage conflict.
- Proficiency in MS Word, Excel, Outlook, and PowerPoint.
- Bachelor's degree, preferably in a science or engineering-related field.