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11 days old

Commissioning, Qualification, Validation (CQV) Manager

Kelly Services
Indianapolis, IN 46202
Kelly is looking for a CQV Manager to join the team!


TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.



**CQV Manager**


The Manager of Commissioning, Qualification, and Validation (CQV) is responsible for equipment commissioning, equipment qualification, and computer systems/process validation to ensure products are manufactured in accordance with current Good Manufacturing Practices (cGMPs).


The Manager of CQV will work across the organization to ensure that commissioning, qualification, and validation activities are compliant with US FDA and EU Regulatory agency requirements.


The position is based in Indianapolis, Indiana, U.S. and reports directly to the Associate Director, Quality Assurance.


**Objectives**


+ Overall accountability for validation activities including equipment commissioning & qualification, computerized system validation, thermal validation, and validation maintenance activities.

+ Lead strategic planning and development of activities for company CQV function, including compliance, capacity, timelines, and directions.

+ Collaborate closely with senior leadership team in meeting organizational goals through establishing and reporting of department metrics.

+ Perform and ensure validation of GMP facilities through management of validation projects of various sizes while providing technical assistance.

+ Act as subject matter expert and resource to peers and colleagues.

+ Develop validation plans for validation projects and work closely with third party service providers through development of statement of work and vendor selection. Oversee and manage vendors on-site with respect to commissioning, qualification, and validation activities.

+ Supervise, train, and direct validation personnel.

+ Ensure appropriate validation activities are included in site or team project plans including tasks, duration, and resources.


**Accountabilities**


+ Remain knowledgeable and current on relevant Good Manufacturing Practices pertaining to commissioning/qualification/validation.

+ Provide subject matter expertise for all CQV activities and programs.

+ Support achievement of facility Key Performance Indicators (KPIs) by ensuring equipment, computer systems, and processes are validated for their intended use.

+ Write, review, approve and assist in execution of commissioning, qualification and validation documentation, including FAT, SAT, IQ, OQ protocols, SOPs, and reports. Ensure appropriate resolution of protocol exceptions.

+ Generate, review and approve CQV associated deviations, CAPAs. Lead and perform investigations as required.

+ Perform CQV associated change control assessments.

+ Serve as the primary point of contact for CQV associated audit requests. Present and defend validation studies during regulatory inspections.

+ Lead or participate in risk assessments and gap analysis.

+ Lead continuous improvement initiatives


**Education and Experience**


+ Engineering, science, or technical degree.

+ 3 years of relevant experience in validation and GMP within the pharmaceutical/biotech or medical device industry.

+ 3 years of experience in CQV.

+ 2 years managing a team of direct reports.


**Critical Competencies**


+ Experience participating in regulatory inspections (FDA, EU, ISO, etc) pertaining to commissioning, qualification, and validation activities.

+ Knowledge of FDA regulations, USP, GAMP

+ Experience with risk assessments, gap assessments, change controls and CAPAs

+ Hands-on experience with authoring, editing, and approving validation documentation.

+ Ability to plan, develop and execute multiple projects under tight timelines.

+ Operate and execute with an extreme sense of urgency.


**Benefits**


+ Health Care Plan (Medical, Dental & Vision)

+ Retirement Plan (401k, IRA)

+ Life Insurance (Basic, Voluntary & AD&D)

+ Paid Time Off (Vacation, Sick & Public Holidays)


\#P1


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-24

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Commissioning, Qualification, Validation (CQV) Manager

Kelly Services
Indianapolis, IN 46202

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