Computer System Validation Specialist
7 days ago
Job Description
KVK Tech is seeking a highly skilled Computer System Validation Specialist to join our team.
About the Role:
- This position involves working as a help desk staff for other cross-functional teams, determining and resolving problems, and implementing solutions.
- The successful candidate will respond to queries, isolated problems, and determine and implement solutions.
- Daily system monitoring ensures that all computer-based systems produce information or data that meet predefined requirements.
Responsibilities:
- Familiarity with software development life cycle and GAMP5 approach to software implementation.
- Collaborate with system owners 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.
- 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, and 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 resolve 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.
Requirements:
- Associates degree in a related field from an accredited college or university preferred.
- One-year pharmaceutical industry experience preferred.
Competencies:
- Applicable knowledge of DEA regulations.
- Maintains a safe working environment.
- Organized.
- Demonstrates a high level of confidence, integrity, and motivation.
- Handles confidential and non-routine information with poise, tact, and diplomacy.
Salary: $60,000-$80,000 per year.
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