Senior Quality Specialist - Computer Systems Validation

Merck•Rockville, MD

11d

About The Position

As a Senior Quality Specialist – Computer Systems Validation, you will perform tasks related to auditing computer system validation and other documentation within the Systems Audits team as part of the Quality Assurance team. The role affects customer, operational, project, and service activities across various teams, and guides and influences peers or management on technical issues and challenges. The position does not offer work authorization sponsorship; external applicants must be eligible to work in the US.

Requirements

Bachelor’s degree in any discipline.
At least 6 years of experience in validation, QA validation, validation testing, or a related area within a pharmaceutical, life sciences, or biotechnology environment.

Nice To Haves

Excellent technical writing skills and the ability to document work accurately and in a timely manner.
Proficient knowledge of FDA and EU computer systems validation and associated regulations and guidance, including cGMP, GLP, ICH, GAMP, data integrity, and Part 11.
Acts ethically and ensures the quality of their own work and that of others.
Collaborates with various teams to identify and implement improvements.
Applies technology to drive digitalization, improve quality, and increase customer value.
Works with agility and drives and implements changes on local and global scales.

Responsibilities

Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11, and other regulatory requirements.
Review validation documentation, including user and functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix requirements, deviations, validation summary reports, decommissioning reports, and system-use documentation.
Collaborate with global, cross-functional teams to accomplish company objectives and team goals, including on-time completion of system go-lives and enhancements.
Manage continuous improvement efforts for the computerized systems validation program.
Support GxP regulatory inspections as needed, including acting as a subject matter expert for Quality GxP computer validation topics.
Provide Computer Validation tester/reviewer training as needed.
Ensure archival of validation documentation in paper and electronic formats.
Monitor industry developments and new or revised SDLC and CSV regulations and guidance for their impact on the organization.
Review and approve deviations/OOS records and CAPAs.
Review and approve change control (GCC) and IT Change Control records.
Provide guidance and/or training for Quality Specialists.