Senior Quality Specialist - Computer Systems Validation

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

11d•$80,600 - $121,000

About The Position

The Senior Quality Specialist – Computer Systems Validation performs auditing of computer system validation and other documentation within the Systems Audits team in Quality Assurance. The position influences technical issues and challenges and supports customer, operational, project, and service activities across teams. Responsibilities include auditing validation deliverables for regulatory compliance, supporting system go-lives and enhancements, improving the validation program, and providing expertise and training. The role does not offer work authorization sponsorship; external applicants must be eligible to work in the United States.

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 promptly.
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 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 locally and globally.

Responsibilities

Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11, and other regulatory requirements.
Review validation documents, 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 achieve company and team objectives, including timely completion of system go-lives and enhancements.
Manage continuous improvement efforts for the computerized systems validation program.
Support GxP regulatory inspections as needed, including serving as a subject matter expert on Quality GxP computer validation topics.
Provide computer validation tester and reviewer training as needed.
Ensure validation documentation is archived in paper and electronic formats.
Monitor industry developments, 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 general and IT change-control records.
Provide guidance and training for Quality Specialists.