Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
Qualified candidates must be experienced in one or more of the following areas of validation:
Equipment Qualification
Process Qualification
The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization.
The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint.
The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process.
The candidate must possess technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle.
The candidate must be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate.
Gown qualification is a plus, with an understanding of clean room practice and cGMP environments.
The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.
Responsibilities:
Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
Must be able to read and understand engineering P&ID’s and turnover documentation.
Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
Complete test method validation, gauge r&r studies and other qualifications or studies to support product testing.
Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
Develop statistically based sampling plans for in-process and final test sequencing.
Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
Support and address comments and suggestions associated with validation and engineering documentation.
Protocol, Deviation, and summary report generation and approval.
Change control, non-conformance and CAPA support.
Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
Requirements.
Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
4 to 7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
Demonstrates excellent organizational and communication skills.
Experience with qualifying medical device manufacturing equipment.
Results oriented with a strong focus on quality principles and conflict resolution.
Excellent technical writing skills with a thorough understanding of good documentation practies.
Experience using temperature mapping equipment including Kaye Validators and Valprobes.
Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
Travel to other sites and offices domestically and internationally as required.