Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant
Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks
Supports and/or owns technical and quality investigations, CAPAs and corrections
Develops and performs any required remediation efforts and associated CAPA plans
Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity
Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation
Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews
Requirements:
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Ability to quickly process complex information and often make critical decisions with limited information.
Proficient in applying process excellence tools and methodologies.
Ability to independently be responsible for a portfolio of ongoing projects.
Ability to pay attention to details and follow the procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a requirement.
Ability to work with others in a team environment.
Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
Ability to identify/remediate gaps in processes or systems.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
Experience with TrackWise, CMMS and Maximo
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.