Source description
About the role
Understanding of current regulations and guidelines (e.g., 21 CFR Parts 11, 210, and 211, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort
Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort
Hands-on experience with the qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation (Experience in at least two of these areas is required)
Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team
Strong time-management skills and the ability to organize and coordinate multiple projects at a time
Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
Ability to prioritize tasks and to keep leadership apprised of performance to timelines
Accepts feedback from a variety of sources and constructively manages conflict
Experience in Oral Solid Dose operations and spray drying is preferable
Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
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