Validation Specialist
For Validation services in the Manufacturing area.
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The Technical Part:
- Bachelor’s Degree in Science with five (5) years of experience and exposure within the Pharmaceutical or Medical Devices industry.
- Excellent reading, writing, and speaking skills in Spanish and English.
- Shift: Administrative and according to business needs
- Experience in:
- Develop and implement validation plans, protocols (IQ,OQ ,PQ), and reports for equipment, processes, and systems.
- Develop test plans and acceptance criteria for validation activities.
- Quality Assurance, Manufacturing, and Engineering, to coordinate validation activities.
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Review and approve changes in procedures and validations from a Quality Assurance perspective.
- Support Quality Improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Support the development of quality engineering and quality compliance roles with the right skill sets for existing processes and product life cycle management.
- Support investigations, bounding, impact evaluations, review and approval of NRs, CAPAs and customer complaints and escalates quality issues as appropriate.
- Review and approve validation protocols and reports to ensure they meet quality standards.
- Identify opportunities for improving validation processes and implement changes to enhance efficiency and effectiveness.
- Work closely with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to coordinate validation activities.
- Pragmatic approach to validation processes, ensuring efficient and effective validation outcomes.
- Identify Manufacturing process defects by disposition of nonconforming material, identifying primary root causes and suggesting corrective and preventive actions.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
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