CQV Project Lead
About The Position
Compli, LLC was founded in 2001 to provide commissioning, validation, and regulatory support services to the life sciences industry. We serve pharmaceutical companies across the U.S. Regarding regulations and compliance, it has never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction, and contractors, which is why clients trust the Compli team. Compli LLC is a full-service regulatory compliance consulting services company with a life sciences division specializing in pharma, biotech, API, Medical devices, and laboratory facilities. We are seeking an experienced Validation professional to join our growing team
Requirements
- Bachelors degree in related life sciences or engineering field
- 7-10 years of GMP experience
- Ability to converse about scientific matters
- Ability to work independently or in collaboration with others
- In-depth understanding and application of validation principles, concepts, practices, and standards
- Proficient in current Good Manufacturing Practices and other applicable regulations
- Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report
- Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards
- Excellent written communication skills with emphasis on technical writing
- Proficient in MS Excel, MS Word, MS Project, MS PowerPoint, and AutoCAD Lite.
Responsibilities
- Function as an owners representative and report to the clients management lead
- Coordinate internal and external resources for the flawless execution of projects
- Able to lead and execute projects to meet clients priorities
- Ensure that projects are delivered on time and within scope.
- Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility
- Develop a detailed project plan to monitor and track progress
- Manage changes to the project scope, project schedule and project costs using appropriate verification techniques
- Measure project performance using appropriate tools and techniques
- Support Client commissioning/validation for facility, utility, equipment, cleaning, and process validation projects
- Prepare and execute commissioning/validation lifecycle documents
- Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
- Write summary reports for validation and qualification protocols
- Support project milestones, priorities, and deadlines
- Write operating procedures for technical equipment and practices and procedures
- Perform system and process risk assessments and analyses
- Schedule and coordinate protocol execution with other departments including manufacturing, facilities, and project management
- Develop project-specific validation plans and strategy
Benefits
- Competitive Pay commensurate with experience
- Work / Life Balance
- Working with a small, close-knit team where you are valued as an individual
- A learning environment and continuous advancement opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
