Cleaning Validation Specialist
Cleaning Validation Specialist
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Job Description
For Quality Risk Management services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Life Sciences or Engineering and five 5 years of exposure within the Pharmaceutical or Medical Device Industry.
- Excellent verbal/written communication skills (English and Spanish)
- Shift: Administrative & according to business needs.
- Experience in:
- Risk Managementusing several tools (FMEA etc.
- Developing cleaning validation studies
- Protocols and reports
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 topquality results to the table. Are you ready to take on this new challenge
AS A PIECE OF FITS YOU WILL: (The daytoday on the job)
- Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations activities escalations and status of assigned tasks.
- Active participation on Contamination Control Strategy team meetings to provide input on activities escalations and status of assigned tasks.
- Serve as Subject Matter Expert to lead Quality Risk Management exercises and author risk assessment for implementation of identified actions.
- Serve as Subject Matter Expert to develop cleaning validation protocols reports executable instructions and implementation of additional data integrity requirements.
- Participate in the revision ofthe cleaning and contamination control strategy documentation records related to the manufacturing stages and steps.
- Lead and/or participate on triage activities to assess change control requirements.
- Issuance or support on change control generation.
- Issuance change control and present it in Change Control Board to pursue approval of the change.
- Review documentation associated to contamination control strategy and cleaning program (cleaning validation master plan risk assessment protocols reports working instructions sampling scheme limit calculations etc..
- Revise SOPs related to cleaning program and contamination control strategy.
- Lead trainings activities provided to manufacturing operators.
- Comply with Individual Learning Plan Requirements including qualification modules for Darwin Trackwise VEEVA (Quality Docs) among others.
- Comply with additional tasks requested by supervisor.
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 familyoriented and focused on our resources wellbeing while providing our Pharmaceutical Medical Device and Manufacturing industryclients with topnotch quality talent.Were FITS!
Are you the next piece
Required Experience:
Senior IC
Employment Type
Contract
