Commissioning & Qualification Consultant
Commissioning & Qualification Consultant
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The consultant operating under general guidance will be responsible for the preparation execution review and approval of commissioning and qualification protocols reports and assessments related to equipment facilities and utilities. Additionally the role will involve drafting equipment and material specifications conduct engineering investigations and addressing issues associated with equipment and facilities.
Responsibilities:
- Author review approve and execute commissioning and qualification documents including protocols for Commissioning Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) across various equipment facilities and utilities.
- Lead and contribute to projects of varying complexity ensuring timely and successful completion of commissioning and qualification activities. Manage personal time and resources effectively to align with departmental and site goals.
- Coordinate all necessary activities related to the execution of commissioning and qualification deliverables.
- Collect and manage all data obtained during commissioning and qualification ensuring data integrity for use in Good Manufacturing Practice (GMP) decision-making processes.
- Ensure that the qualified state of systems is maintained and any impacts are addressed in compliance with Lupins policies and procedures.
- Assess the impact of changes to qualified systems and implement best practices in validation to continuously enhance the sites validation program.
- Assist in troubleshooting and resolving deviations or failures identified during the commissioning or qualification of critical equipment facilities or utilities ensuring product quality and patient safety.
- Participate in presenting results to regulatory agencies in collaboration with Lupin Research Inc.
- Associate degree with a minimum of 1 years of relevant experience.
- Strong understanding of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
- Extensive knowledge of 21 CFR 211 21 CFR 820 Part 11 and applicable ISO standards.
- Familiarity with ISPE Guidelines is preferable.
- This position requires a minimum understanding of pharmaceutical regulatory standards.
Employment Type
Full Time
