Senior Quality System Manager Consultant
As part of our development, we are recruiting a Senior Quality System Manager Consultant to join our teams.
Responsibilities:
* Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to GMP Part 1 and 2 or the EU Guidelines to GMP Medicinal Products for Human and Veterinary Use.
* Provide immediate support to operations and quality control staff to address compliance related concerns.
* Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
* Audit internal quality system elements in manufacturing and operational support areas.
* Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
* Perform external audits of suppliers/vendors/off-site facilities.
* Act as a customer interface during on-site audits, conference calls and other standard means of communication.
* Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
* Prioritize and manage a variety of projects simultaneously.
* May need to lead and direct the work of others. Review and approve validation documents.
* Review and Master Batch Records (MBR) and supporting documents.
* Perform review/release of batch records, as needed.
Your Profile:
* 5-10 Years Experience
* Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
* GMP compliance and Part 11 compliance knowledge preferred.
* Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
* Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
* The ability to interface and communicate directly with clients is required.
* Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
Do you want to join the consulting world in a human-sized company that values the individual and performance?
To share your skills within a cohesive team where experiences are freely shared?
CONSULTYS is open to all talents and is committed to diversity and inclusion.
Seniority Level:
Associate
Employment Type:
Full-time
Job Function:
Quality Assurance
Industries:
Business Consulting and Services and Biotechnology Research
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