Job ID : 27711
Location : New Jersey, NJ
Company Name : LS Solutions Inc.
Job Type : Full-Time, Contract, Training
Industry : Biotech/Pharmaceutical
Salary : $57,000 - $60,000 per year
No. of Positions : I Have Ongoing Need To Fill This Role
Required Skills : Computer Systems Validation
Benefits : Medical Insurance
Job Description :
- Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry.
- Required Bachelor's degree in pharmaceutical Science OR related field of study.
- Schedule and plan equipment and process qualification workload to meet approved schedules.
- Handle multiple projects and be able to work independently as required.
- Develop GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional Design Specifications, Configuration Specifications, Testing Protocols (IQ/OQ/PQ/VSR/Deviations), User Acceptance testing, Traceability matrix, System and Validation reports, SOPs, Change Control Documentation, and Risk assessment/FMEA reports as required.
- Establish critical parameters, plan, design, and implement validation projects and protocols.
- Ability to author, execute, and thoroughly review complex protocols and documentation.
- Coordinate validation activities with other departments.
- Stay current with industry qualification trends through FDA, ISPE, EU and bench marked companies.
- Consult, coordinate, cross-function with various personnel within the company and externally.
- Have the ability to problem solve with minimal oversight, including conducting research to aid in the resolution of issues that arise.
- Train and mentor other Validation personnel as necessary.
- Determine and acquire necessary supplies and equipment for validation activities (Planning).
- Administer the site Change Control/Management Program.
- Make decisions representing QA in multi-functional teams.
- Plan and assist with the Global serialization project (as necessary).
- Familiarity and experience with TrackWise, LIMS, ComplianceWire, JDE, GAMP is desirable
- Minimum Bachelor’s Degree
- Significant experience in pharmaceutical/biotechnology or related industry, as well as Quality Assurance
- Cleaning Validation/Process Validation experience preferred
- Experience with commissioning/qualification of equipment, change management or change control experience
- Independent and flexible worker that can readily adapt to changing priorities in a fast-paced environment
- Demonstrated attention to detail and excellent oral and written communication skills