Senior Validation Lead Analyst - Life Sciences - ITQ&C
SENIOR VALIDATION LEAD ANALYST – REMOTE / VIRTUAL ROLE - FULL-TIME
We are looking for a Senior Validation Lead Analyst with experience in Computer System Validation and TrackWise to join our ITQ&C team.
The Senior Validation Lead Analyst’s primary responsibility is to support one or more of Sikich’s software implementation/development projects. The role includes acting as the primary validation Subject Matter Expert (SME) for the software development lifecycle, authoring, reviewing, executing validation deliverables in alignment with client and internal based CSV, SDLC and Change Management SOP’s, and participating in system releases as the Validation Analyst.
About Sikich: Sikich is a global company specializing in technology-enabled professional services. With more than 1,000 employees, Sikich draws on a diverse portfolio of technology solutions to deliver transformative digital strategies.
Learn about our firm here.
- Software validation support, such as Validation Planning, System Testing, and Validation Reporting.
- Review and update of existing documentation to reflect the validated state of systems.
- Support Risk Assessments to determine compliance needs and assist in maintaining compliance to applicatory regulations, such as Computerized System regulatory requirements and applicable requirements for regulatory agencies
- Assist and support as needed in author training material, including SOPs, Quality Manuals, and Work Instructions
- Support the implementation of IT Quality Programs such Data Integrity, Quality Risk Management, and Training
- Validation and Testing Services for IT Implementations as directed by the Project/Program Management.
- Conduct the Periodic Review, Vendor/quality Assessment, GxP Assessment and Risk Assessment
- Working with cross-functional areas including business users, IT leads, and upper management to streamline quality processes and understanding intended use of quality systems
- Provide all other assigned validation and IT quality activities
- BA/BS Degree in IT, Business, related field, or equivalent work experience
- 8+ years of experience in technical writing, test scripts/cases authoring and execution.
- 8+ years of experience with IT projects or software implementations in Pharmaceutical or Life Sciences domain.
- 4+ years experience with Quality Management System (QMS) using TrackWise, SAP QM, VeeVa and/or Laboratory Information System (LIMS)
- Strong validation skills in the areas of computerized system validation and quality assurance
- In-depth understanding of cGMPs, GAMP 5 Risk-Based Approach, 21 CFR Part 11 and current industry / FDA compliance
- Experienced in preparing and executing validation documents in alignment with client-based CSV, SDLC and Change Management SOP’s.
- Experience with industry software testing tools (i.e. HPQC, HP ALM, JIRA, etc.) is a plus.
- Understanding of GxP regulations and computerized system validation methodologies.
- Excellent communication (verbal and written), teamwork, and organizational skills
- Ability to develop and meet project schedules, along with contingency plans
- Flexible time off (4-5 weeks)
- Paid holidays
- Holiday break – we close the firm every year between Christmas and New Year’s Day
- Health, dental and vision insurance options
- 401(k) match
Sikich LLP is an Equal Opportunity Employer M/F/D/V