Commissioning Qualification Validation Specialist
Posted on :
17-10-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1717647
Responsibilities:
- 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
- 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).
Employment Type
Full Time
Key Skills
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