Quality Validation Specialist
Quality Validation Specialist
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Job Description
For Validationsservices in the Quality area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Sciencewith three to five(3 - 5) years of validationexperience andexposurewithin 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:
- Ensure all validation activities are documented accurately and comply with regulatory requirements and industry standards.
- 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.
- InvestigationsDeviations processandNon-conformance.
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 of your (many) talents. Being the Piece means youre 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)
- Ensure all validation activities including protocols and reports are meticulously documented accurately executed and comply fully with regulatory requirements (e.g. FDA EU GMP) and industry standards.
- Review and approve validation documentation to ensure robust quality standards are met.
- Proactively identify and implement improvements to existing validation processes enhancing theirefficiency effectiveness and compliance.
- Actively partner with Quality Assurance Manufacturing and Engineering teams to seamlessly coordinate validation activities and ensure integrated operational excellence.
- Support and when necessary lead investigations for quality notifications (e.g. deviations non-conformances complaints). This includes authoring investigation reports conducting thorough root cause analyses and formulating effective Corrective Actions/Preventive Actions (CAPAs).
- Collaborate closely with manufacturing and technical services teams to troubleshoot and resolve complex process and product-related issues.
- Work effectively with cross-functional partners to execute remediation plans and CAPAs ensuring timely closure of investigations and sustained compliance.
- Ensure all investigations and complaints are drafted to meet site-specific timelines and are completed before the impacted product(s) release.
- Coordinate and ensure the involvement of cross-functional teams with appropriate subject matter expertise when necessary to facilitate thorough and effective investigations.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Manager
Employment Type
Contract
