Computerized System Validation Specialist

Job description

The CSV Specialist will work as help desk staff for other cross functional teams as appropriate to determine and resolve problems. Respond to queries, isolated problems and determine and implement solutions. Perform daily system monitoring to ensure that all computer-based system will produce information or data that meet predefined requirements.

Key Duties and Responsibilities: (CSV Specialist):

• Familiarity with software development life cycle, GAMP5 approach to software implementation

• 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 SOP’s 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, 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/issues based on internal compliance issues, industry best practices as well as latest regulatory guidance’s and regulatory updates

• Identify, communicate and escalate project and compliance related issues associated with their projects to project Manager/Management

• Conduct training to individuals performing various roles within validation projects

• Review and assess the impact of new Patches to validated GxP systems and validation of new patches

• Experience in project Management practices and assessing GxP risk, functional and usage risk for any given GxP Application techniques

• 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 skills, planning skills and must work effectively within teams

• Initiate and resolving any non-conformance observes during periodic reviews through change and incident management

• Participate and coordinate with CFT for new projects

• Must have sound understanding of Drug Regulations, Pharmacopeia, Regulatory Requirement, Laboratory compliance and adherence to cGMP requirements

• Other duties as assigned

Technical Competencies: (CSV Specialist):

• One-year pharmaceutical industry experience preferred

• Applicable knowledge of DEA regulations

• Maintains a safe working environment

• Must be able to multi-task and work in a fast-paced environment

• Strong reading, writing, organization, and communication skills are required

• Ability to resolve end user problems quickly

• Demonstrates a high level of confidence, integrity, and self-motivation

• Handles confidential and non-routine information with poise, tact, and diplomacy

• Ability and willingness to work cooperatively with others

• High degree of discretion dealing with confidential information

• Knowledge of Microsoft Office products and telephone protocol

• Must manage time effectively and possess the ability and judgment to escalate support requests if necessary

Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.

Job Type: Full-time

Salary: $50,000.00 - $130,000.00 per year

Schedule:

• 8 hour shift

• Monday to Friday