Job Description
- 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
Responsabilités :
- 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) #LI-Remote