K V K Tech
Computer Systems Validation Associate
K V K Tech, Newtown, Pennsylvania, United States, 18940
Overview
CSV Associate will work as help desk staff for cross-functional teams as appropriate to determine and resolve problems. The CSV Associate will respond to queries, resolve problems, and determine and implement solutions. This position requires the ability to resolve end user problems quickly. You must have excellent communication skills (both verbal and written), must manage time effectively, and have strong organizational skills. You must also possess the ability and judgment to escalate support requests if necessary. Responsibilities Collaborate with system owner to develop URS, Design Qualifications, Functional Requirements, Unit test scripts, UAT scripts, Validation Plans and Protocols, Validation summary report and Traceability matrix Develop procedures specific to GxP Application SOPs and provide SOP review for new systems Perform Part 11 Assessments for new and existing computer systems Perform periodic reviews of validated GxP Systems Maintain GxP System log and update as necessary Participate in cross-functional project team meetings Execute the validation protocols and test scripts per Regulatory and GAMP guidance Perform risk assessments for GxP systems Identify and implement opportunities for continuous improvement related to validation or other compliance practices Identify, communicate and escalate project and compliance related issues to project Manager/Management Conduct training for individuals performing various roles within validation projects Review and assess the impact of new patches to validated GxP systems and validate new patches Initiate and resolve any non-conformance observed during periodic reviews through change and incident management Coordinate with cross-functional teams for new projects Other duties as assigned
Education & Experience
Associates degree in related field from an accredited college or university preferred One-year pharmaceutical industry experience preferred Technical competencies/ Certifications/ Licenses: Applicable knowledge of DEA regulations Sound understanding of Drug Regulations, Pharmacopeia, Regulatory Requirement, Laboratory compliance and adherence to cGMP requirements Knowledge of pharmaceutical principles, practices and applications
Demonstrates ability to perform detail-oriented work with a high degree of accuracy Effective time management and interpersonal skills Strong organizational and planning skills; ability to work effectively within teams Experience in project management practices and assessing GxP risk, functional and usage risk for GxP applications Familiarity with software development life cycle and GAMP5 approach to software implementation Maintains a safe working environment Organized with high levels of confidence, integrity and motivation Handles confidential and non-routine information with poise, tact, and diplomacy
Physical Demands & Work Environment
Physical demands: walking, sitting, handling tools or controls, reaching with arms, balance, stooping, crouching, bending, talking and hearing. Ability to lift and/or move up to 20 pounds. Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, and depth perception. Work environment: N/A
Job Details
Job Type: Full-time Location: Moorestown, NJ Salary: $68,300.00$83,800.00 KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status. We encourage you to apply if you feel that you are a match! We look forward to hearing from you. Referrals increase your chances of interviewing at KVK Tech, Inc. by 2x Apply for this position #J-18808-Ljbffr
CSV Associate will work as help desk staff for cross-functional teams as appropriate to determine and resolve problems. The CSV Associate will respond to queries, resolve problems, and determine and implement solutions. This position requires the ability to resolve end user problems quickly. You must have excellent communication skills (both verbal and written), must manage time effectively, and have strong organizational skills. You must also possess the ability and judgment to escalate support requests if necessary. Responsibilities Collaborate with system owner to develop URS, Design Qualifications, Functional Requirements, Unit test scripts, UAT scripts, Validation Plans and Protocols, Validation summary report and Traceability matrix Develop procedures specific to GxP Application SOPs and provide SOP review for new systems Perform Part 11 Assessments for new and existing computer systems Perform periodic reviews of validated GxP Systems Maintain GxP System log and update as necessary Participate in cross-functional project team meetings Execute the validation protocols and test scripts per Regulatory and GAMP guidance Perform risk assessments for GxP systems Identify and implement opportunities for continuous improvement related to validation or other compliance practices Identify, communicate and escalate project and compliance related issues to project Manager/Management Conduct training for individuals performing various roles within validation projects Review and assess the impact of new patches to validated GxP systems and validate new patches Initiate and resolve any non-conformance observed during periodic reviews through change and incident management Coordinate with cross-functional teams for new projects Other duties as assigned
Education & Experience
Associates degree in related field from an accredited college or university preferred One-year pharmaceutical industry experience preferred Technical competencies/ Certifications/ Licenses: Applicable knowledge of DEA regulations Sound understanding of Drug Regulations, Pharmacopeia, Regulatory Requirement, Laboratory compliance and adherence to cGMP requirements Knowledge of pharmaceutical principles, practices and applications
Demonstrates ability to perform detail-oriented work with a high degree of accuracy Effective time management and interpersonal skills Strong organizational and planning skills; ability to work effectively within teams Experience in project management practices and assessing GxP risk, functional and usage risk for GxP applications Familiarity with software development life cycle and GAMP5 approach to software implementation Maintains a safe working environment Organized with high levels of confidence, integrity and motivation Handles confidential and non-routine information with poise, tact, and diplomacy
Physical Demands & Work Environment
Physical demands: walking, sitting, handling tools or controls, reaching with arms, balance, stooping, crouching, bending, talking and hearing. Ability to lift and/or move up to 20 pounds. Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, and depth perception. Work environment: N/A
Job Details
Job Type: Full-time Location: Moorestown, NJ Salary: $68,300.00$83,800.00 KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status. We encourage you to apply if you feel that you are a match! We look forward to hearing from you. Referrals increase your chances of interviewing at KVK Tech, Inc. by 2x Apply for this position #J-18808-Ljbffr