- Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols (first in kind) and Validation/Qualification Policies.
- Initiate an own Change Controls; provide validation assessments and remediation plans as required by the system/equipment/components.
- Develop Commissioning and Qualification Plans.
- Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211 and adherence to ICH Q7.
- Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
- Lead discussions and provide guidance to personnel during risk assessments.
- ssure adherence to Q9 "Quality Risk Management".
- ssure Compliance with FDA and EU Regulations.
- Evaluate, document, and develop investigations attributed to qualifications failures.
- uthor Summary Reports, events, and applicable protocol amendments.
- Execute and/or provide support during protocol executions.
- ssure all the qualification items are tracked and successfully completed.
- Perform GAP analysis and provide recommendations for existing qualifications.
- bility to work in a fast pace, team-oriented environment.
- Technical problem-solving ability, manage multiple priorities, provide logical and analytical reasoning, technical writing ability, and self-training.
- Potential to manage engineering projects from design through qualification, depending on candidates experience and skill set.
- Candidate must adapt the work schedules to perform required qualification activities. This may require overnight and/or weekends.
- Complies with all company policies and standards
- Performs other functions as required or assigned
- BS or MS Degree in related Engineering field.
- t Least 4 Years of experience in automated systems, project management is a plus.
- t least 2 years' experience commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies.
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