Commissioning & Qualification Consultant

Commissioning & Qualification Consultant

Location : Coral Springs, FL

Type : On-site

Schedule : 8 : 00 am-5 : 00 pm (projects may extend beyond 1st shift and / or into weekends)

Type Of contract : : Temporary 6 Months

Pay rate : : 20- 35 Per hour

DESCRIPTION :

The Commissioning & Qualification Consultant will operate under general guidance to prepare, execute, review, and approve commissioning and qualification protocols, reports, and assessments related to equipment, facilities, and utilities.

This role involves drafting equipment and material specifications, conducting engineering investigations, and addressing issues associated with equipment and facilities.

Key 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 the timely and successful completion of commissioning and qualification activities.

Effectively manage personal time and resources to align with departmental and site goals.

• Coordinate all necessary activities related to the execution of commissioning and qualification deliverables.
• Collect and manage data obtained during commissioning and qualification, ensuring data integrity for use in Good Manufacturing Practice (GMP) decision-making processes.
• Ensure the qualified state of systems is maintained, addressing any impacts in compliance with company policies and procedures.
• Assess the impact of changes to qualified systems and implement best practices in validation to enhance the site's validation program.
• Assist in troubleshooting and resolving deviations or failures during 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 company representatives.

REQUIREMENTS :

• Education & Experience :
• Associate degree with a minimum of 1 year of relevant experience.
• Skills & Knowledge :
• 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.
• A minimum understanding of pharmaceutical regulatory standards is required.

About Us :

ttg Talent Solutions is an Equal Opportunity Employer and recruiting agency. We are committed to creating an inclusive and diverse work environment and welcome applications from all qualified candidates regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status.

Please note that all offers of employment are contingent upon the successful completion of a drug test and background check.

We maintain a drug- and substance-free workplace to ensure the safety and well-being of all employees.

At ttg, "We believe in making a difference One Person at a Time," ttg OPT.