Website Requires BS and aseptic pharmaceutical experience
Full-time / days / Mo-Fr. Responsible for equipment validation, cleaning validation and computer system validations and assurance of GxP compliance to 21 CFR part 210, 211 and 820 as relates to manufacturing and fill/pack equipment. Ensures change controls, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP) and meet applicable GAMP requirements. Coordinates validations with section supervisors to ensure timeliness with minimal disruption of production schedules. Writes validation protocols, final reports, and summaries of work for release of equipment, systems, instruments, components, utilities tested.
Essential Duties and Responsibilities:
• Writes computer related system validation protocols, manufacturing equipment and master plans and supervises and/or performs testing related to computer related system validation.
• Writes, assesses and summarizes lyophilizer qualification protocols.
• Writes packaging equipment validation protocols and master plans and supervises and/or performs testing related to packaging equipment validation.
• Monitors the qualification and validations process to determine accuracy and reliability of equipment, systems, instruments and processes; and effects repairs/adjustments and changes based on results.
• Analyzes data and writes and/or reviews final reports and summaries for validation protocols.
• Develops, reviews and recommends changes to validation procedures.
• Conducts special projects as directed by management.
• Provides technical advice on new equipment and systems and modification to existing equipment and systems to ensure validation/certification and servicing can be provided.
• Provides technical assistance and training for personnel.
• Schedules validations with section supervisors to ensure timely completion with minimal disruption of production schedule.
• Recommends changes in policies and procedures, to management, to enhance the company’s ability to conform to directives and regulations.
• Notifies and recommends to management course of action when critical instruments, systems or processes are found to be out of specifications.
• Interacts as needed with outside vendors and consultants.
• Other duties may be assigned
Directly supervises six employees in the Validations Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Education and/or Experience:
B.S. in Computer Engineering or Physical Sciences (or equivalent) with a minimum of two years directly applicable experience. Must have experience in high level mathematics (i.e., calculus) and technical writing. Knowledge of regulations FDA, ISO 9000-3, PIC/S guides to cGMP, GAMP4 and GAMP 5 based on GAMP V-Model Framework, EUGMP Annex 11 “Computer Systems.”
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