Sr. Analyst, IT Validation Services

Job Description

Job Title: Sr. Analyst, IT Validation Services

Location: Remote

Duration: 12 Months

Pay Range: $30/hr-$35/hr on W2 (DOE)

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

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.Benefits Info: Russell Tobin/Pride Global offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

Fully remote