Offer summary

Qualifications:

Bachelor's degree or equivalent training/certification with at least 5 years of experience in computer systems validation and change management., Expertise in Computer System Validation (CSV) and Systems Development Life Cycle (SDLC) methodologies., Strong written and verbal communication skills, particularly in Good Documentation Practices (GDP)., Technical proficiency in MS Office, SAP, LIMS, Veeva Vault, and ServiceNow..

Key responsibilities:

Create, review, and approve Computer System Lifecycle deliverables for projects and change controls.

Implement effective validation strategies and oversee test execution for cross-functional teams.

Build relationships with business counterparts to ensure compliant computer system solutions.

Collaborate with Information System Quality Assurance to ensure compliance on all IT projects and audits.

Job description

Description:
Primary Responsibilities
- Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls:
  - Validation Plans/Summary Reports
  - Risk Assessments
  - User Requirements
  - Specifications
  - Test Plans
  - Test Scripts: IQ, OQ or PQ
- Assess and implement the most effective validation strategy for each activity.
- Oversee test execution for cross-functional teams, including training, tracking, and reviews.
- Build strong relationships with business counterparts to understand processes and requirements, ensuring delivery of compliant computer system solutions.
- Work effectively with IT colleagues to ensure compliance with validation processes and proper documentation.
- Collaborate with Information System Quality Assurance (ISQA) to ensure compliance on all projects, procedures and audits related to Information Technology.
Education and Experience Requirements
- BS/Equivalent Training/Certification and minimum of 5 years of relevant experience in computer systems validation, change management and systems development life cycle methodologies.
  
  Necessary Knowledge, Skills, and Abilities
- Expertise in Computer System Validation (CSV), Systems Development Life Cycle (SDLC) methodologies and CSV regulations, standards, and best practices
- Working knowledge of Computer Software Assurance (CSA) guidance and its applicability.
- Excellent written and verbal communication skills with a focus on Good Documentation Practices (GDP).
- Technical knowledge of the following computer systems and software (at a minimum):
  - MS software packages such as Outlook, Word, Excel, PowerPoint and MS Project
  - SAP, LIMS, or other Manufacturing, Distribution and Laboratory systems
  - Veeva Vault
  - ServiceNow
- Robust knowledge and understanding of pharmaceutical manufacturing, packaging, operations, quality, and supply chain processes and related systems.
- Working knowledge of project management principles, and ability to operate under tight timelines, within budget and to specified quality and compliance goals.
- Solid relationship and conflict management skills, and ability to navigate complex, fast-moving, business environments in a self-directed manner.
Supervisory Responsibilities (if applicable):
- There are no supervisory responsibilities expected in this position.
Summary of Work:
Job Title: Sr. Analyst, IT Validation Services

Department: Information Technology

Length of Assignment: 12 Months

Work Location: REMOTE

Working days and Hours: Monday – Friday 35 hours (9AM-5PM)