Airswift is looking for a Commissioning & Qualification Specialist to work with one of our major clients in Birmingham, AL
Responsibilities
- Develop URS, SIC and SRA for new and existing aseptic facilities and equipment.
- Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and according to specifications.
- Perform operational qualification (OQ) and performance qualification (PQ) activities to verify that systems operate as intended under all conditions.
- Ensure all documentation is compliant with regulatory requirements and internal quality standards.
- Conduct risk assessments and implement mitigation strategies for aseptic processes.
- Proficient in the use of word processing, spreadsheet and presentation software programs. Proficient in use if Kaye Validator AVS and Val Probe Systems.
Knowledge on following equipment qualifications:
- Homogenizers
- Pump Skids
- SIP & CIP Skids
- Temperature control units
- Tanks
- Requalification of CTU’s
Qualifications:
- Bachelor’s degree preferably in Engineering or Science discipline.
- 3 to 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment
- Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs.
Additional Information
- Develop and implement validation plans for computerized systems, ensuring that systems are compliant with regulatory standards and internal policies.
- Conduct risk assessments to identify potential issues related to system functionality and data integrity.
- Create and maintain comprehensive documentation, including system classification, system overview, test scripts, and reports that demonstrate compliance with regulatory requirements.
- Execute CSV protocol, to verify that systems function as intended.
- Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity
- Comprehensive knowledge of pharmaceutical manufacturing equipment and processes
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