BA/MA degree in engineering/scientific field, 5-8 years QA/validation experience with BS, 2-5 years with MS, or 0-2 years with PhD, Strong knowledge of QA/validation principles, GMP operations, cGMPs.
Key responsabilities:
Review and audit system validation deliverables
Collaborate with global teams for project objectives
Continuous improvement in validation program
Support GxP inspections and regulatory compliance
Monitor industry regulations on CSV impact
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Black 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.
Our 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, Biotech
Responsibilities
Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements
Review 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 activities
Collaborate 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 enhancements
With 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 mindsets
Provide support for GxP regulatory inspections, as needed, including acting as subject matter expert for Quality GxP computer validation topics
Monitor industry, new/revised regulations around CSV and guidance for impact to the organization related to computer system validation
Review and approve deviations / OOS records and CAPAs
Review and approve change control and IT/Digital Change Control records
Review and approve Periodic Reviews for Computer Systems
Skills
Requires 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 PhD
Exposure in Quality Assurance functions, with experience solving problems and process improvement techniques
Ability to translate complex processes and systems into a meaningful set of recommendations and/or enhancements
Excellent understanding of QA principles, validation principles, industry practices, and standards with demonstrated ability to apply these to GMP operations
Ability to interact effectively with all levels of personnel within the organization
Excellent interpersonal skills and the ability to prioritize multiple tasks. Ability to utilize a team-oriented approach to project management and problem resolution
Demonstrated knowledge of cGMPs in a manufacturing environment
Strong independent judgement and decision-making abilities
Demonstrated problem detection and problem resolution skills
Demonstrated leadership skills
Ability to take initiative and work independently with minimal oversight
Must possess demonstrated organizational skills
Must possess excellent verbal and written
Remote: Software Quality Oversight (235437)
About Black Diamond Networks
Black 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.
Required profile
Experience
Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
English
Check out the description to know which languages are mandatory.