Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries.
Our Project Managers will oversee the qualification and requalification of equipment used to manufacture and test biologics, drug products, etc. at client sites. The Project Manager will evaluate the equipment, utilities, systems and procedures used in development, production, and holding of pharmaceutical products and determine a validation approach. The individual should have experience with current US and international regulations, guidance, industry best practice in one of the following areas of validation: facilities, utilities, and equipment qualifications, process validation, analytical method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. The Project Manager is also responsible for client relations at the job site, including but not limited to on-going assessment of current client needs in order to offer solutions and services to the client and will seek and solicit prospective clients as well.
Responsibilities include:
- Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan. Write validation site specific and multi-site procedures. Support implementation of validated systems change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies and manufacturing documentation review and approval. Available to travel nationally and internationally.
- Present Quality Agents service offerings to prospective clients
- Constantly seek new client opportunities
- Participate in the integration, installation, testing, validation and deployment of new applications and systems
- Write, review, and/or execute validation plans, IQ/OQ/PQ protocols and SOPs for equipment
- Serve as system administrator with responsibility for user account maintenance
- Troubleshoot and resolve equipment issues at various client sites
- Drive communication with clients and serve as primary point of contact for cleaning, manufacturing and validation issues
- Perform risk assessments to determine criticality and impact of user reported issues
- Participate in sponsor and regulatory audits.
- Maintains up-to-date knowledge of validation requirements, practices and procedures.
- Participate as lead for facilities upgrades and major construction projects
- Cleaning validation and verification
- Sterility validation, medial fill
- Process Validation of biological process
- Filter and method validation
Skill Level and Requirements:
- Able to problem solve and troubleshoot.
- Understand existing and new business processes and requirements to ensure proper implementation and validation of systems
- Thorough knowledge of 21 CFR Part 11, Annex 11, GAMP5, 21 CFR Part 58 and industry best practices.
- Strong technical writing skills
- Proficient in Microsoft Word, Excel, Power point, and Project
- Proficiency with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired.
- Able to read P&ID, Isometric and "As Built" drawings.
- Experience performing IQ/OQ on large automated systems/process equipment and the computerized system lifecycle associated with it
- FAT experience with large automated systems
- Experience using statistical tools is a plus to analyze data captured during validation studies.
Minimum Requirements:
- BS in a technical discipline (Engineering, chemistry, microbiology, biology) or equivalent work experience
- 10+ years of experience in management and validation.
- Current driver’s license and auto insurance
Quality Agents offers a full suite of benefits for full-time employees including:
- Health, dental and vision insurance
- Life, AD&D and disability Insurance
- Health savings account for participants in our health plan
- 401k retirement plan
- Paid vacation
- Paid sick leave
- Paid holidays
Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.
