Remote: Software Quality Oversight (235437)

Job DescriptionOur Client is looking for a Consultant to come on for a 6 plus month project. This Consultant will be doing the Quality Oversight of CSV for the site. They will be reviewing and approving CSV protocols, test scripts, and documents for the group. CSV is a MUST for this role but the consultant won’t be doing any execution work for the CSV. The work is all oversight of CSV from a Quality perspective. This Consultant will be supporting manufacturing. The systems are Delta V, Historian, and Maximo. Laboratory CSV systems would also be a nice to have, they use LIMS. 7-10 years experience and Pharmaceutical/Biotech experience. Most Important Skills: Quality Oversight of CSV, Review/Approvals of CSV Documentation, Review/Approval of test scripts, Manufacturing, Pharmaceutical, BiotechResponsibilitiesReview and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirementsReview validation documentation – such as user requirements, 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 (system admin, user admin procedures)Responsible for QA oversight of the development and implementation of Quality, manufacturing, and laboratory systems/processes to facilitate new projects and continuous improvement activitiesCollaborate with global, cross-functional teams to accomplish company objectives and team goals, including but not limited to, on-time completion of system go-lives and enhancementsWith Manager support and guidance, identify and implement continuous improvement efforts for the computerized systems validation program to ensure alignment with regulatory regulations/guidance as well as clients mindsetsProvide support for GxP regulatory inspections, as needed, including acting as subject matter expert for Quality GxP computer validation topicsMonitor industry, new/revised regulations around CSV and guidance for impact to the organization related to computer system validationReview and approve deviations / OOS records and CAPAsReview and approve change control and IT/Digital Change Control recordsReview and approve Periodic Reviews for Computer SystemsSkillsRequires a Bachelor’s or Master’s degree (engineering or scientific discipline)QA CSV, QA validation, validation tester or related technical field within a pharmaceutical or biotechnology environment with 5-8 years experience with BS degree, 2-5 years of experience with MS degree or 0-2 years experience with PhDExposure in Quality Assurance functions, with experience solving problems and process improvement techniquesAbility to translate complex processes and systems into a meaningful set of recommendations and/or enhancementsExcellent understanding of QA principles, validation principles, industry practices, and standards with demonstrated ability to apply these to GMP operationsAbility to interact effectively with all levels of personnel within the organizationExcellent interpersonal skills and the ability to prioritize multiple tasks. Ability to utilize a team-oriented approach to project management and problem resolutionDemonstrated knowledge of cGMPs in a manufacturing environmentStrong independent judgement and decision-making abilitiesDemonstrated problem detection and problem resolution skillsDemonstrated leadership skillsAbility to take initiative and work independently with minimal oversightMust possess demonstrated organizational skillsMust possess excellent verbal and writtenRemote: Software Quality Oversight (235437)About Black Diamond NetworksBlack Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.