JobRialto
Commissioning and Qualification Consultant
JobRialto, Coral Springs, Florida, United States,
Job Summary:
The Commissioning and Qualification Consultant will be responsible for preparing, executing, reviewing, and approving protocols, reports, and assessments related to the commissioning and qualification of equipment, facilities, and utilities.
The role includes drafting equipment specifications, conducting engineering investigations, and troubleshooting issues while ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
Key Responsibilities:Author, review, approve, and execute commissioning and qualification protocols for Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) across various systems.Lead and manage commissioning and qualification projects, ensuring timely completion and alignment with site goals.Coordinate all activities related to commissioning and qualification deliverables.Collect and manage data obtained during commissioning and qualification, ensuring data integrity for GMP decision-making.Maintain the qualified state of systems and address any impacts in compliance with company policies.Assess system changes and apply best practices to enhance validation processes.Troubleshoot and resolve deviations or failures identified during commissioning or qualification.Present results to regulatory agencies as needed.Required Qualifications:
Associate degree with at least 1 year of relevant experience.Strong understanding of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).Knowledge of 21 CFR 211, 21 CFR 820, Part 11, and applicable ISO standards.Familiarity with ISPE Guidelines preferred.Preferred Qualifications:
Bachelor's degree in engineering, life sciences, or related field.Experience with pharmaceutical regulatory standards and validation processes.Strong organizational skills with the ability to manage multiple projects.Excellent communication and collaboration skills for cross-functional teamwork.Experience with troubleshooting and problem-solving in a regulated environment.
Education:
Bachelors Degree
The Commissioning and Qualification Consultant will be responsible for preparing, executing, reviewing, and approving protocols, reports, and assessments related to the commissioning and qualification of equipment, facilities, and utilities.
The role includes drafting equipment specifications, conducting engineering investigations, and troubleshooting issues while ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
Key Responsibilities:Author, review, approve, and execute commissioning and qualification protocols for Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) across various systems.Lead and manage commissioning and qualification projects, ensuring timely completion and alignment with site goals.Coordinate all activities related to commissioning and qualification deliverables.Collect and manage data obtained during commissioning and qualification, ensuring data integrity for GMP decision-making.Maintain the qualified state of systems and address any impacts in compliance with company policies.Assess system changes and apply best practices to enhance validation processes.Troubleshoot and resolve deviations or failures identified during commissioning or qualification.Present results to regulatory agencies as needed.Required Qualifications:
Associate degree with at least 1 year of relevant experience.Strong understanding of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).Knowledge of 21 CFR 211, 21 CFR 820, Part 11, and applicable ISO standards.Familiarity with ISPE Guidelines preferred.Preferred Qualifications:
Bachelor's degree in engineering, life sciences, or related field.Experience with pharmaceutical regulatory standards and validation processes.Strong organizational skills with the ability to manage multiple projects.Excellent communication and collaboration skills for cross-functional teamwork.Experience with troubleshooting and problem-solving in a regulated environment.
Education:
Bachelors Degree