Sobre o trabalho
Candidate will work in Batch Release with the responsibilities of the Quality Assistant position to perform a timely and efficient cGMP and quality review of batch record documentation to ensure prompt batch disposition and release. This person will serve as reviewer and/or approver for required documentation in a pharmaceutical manufacturing setting, ensuring compliance to FDA regulations and plant procedures. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained and material is readily available. In addition, the role will be responsible for training within the department, new hire GDP training and training for other departments as it relates to review of documentation (batch record or other related).
Responsibilities:
- Reviews all batch documentation for accuracy and completeness according to cGMP’s to ensure timely release of batches. Reviews supporting documentation, as needed.
- Ensures all GMP’s, Work Procedures and SOP’s are followed and adheres to internal/external guidelines, specification and regulatory requirements during review.
- Identify exceptions and report exceptions to production and ensure deviations are communicated and initiated.
- Effectively resolve documentation discrepancies and issues a timely manner.
- Responsible for final batch disposition based on review of all associated documentation.
- Build quality into the batch release process by maintaining compliance to all quality requirements.
- Train all new department members on all aspects of the batch release process.
- Develop and maintain department Training Course Plans.
- Train other departments in areas related to batch release (document review, label review/approval, etc.).
- Perform training as part of new employee orientation for GDP and maintain the GDP training materials with routine updates.
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Profile/Experiences
- High School Diploma or Equivalent
- Excellent verbal and written communication skills
- Proficient in Microsoft Office
- College credits in biology, chemistry, or science related courses is preferred
- Experience in manufacturing is preferred
- Knowledge of good documentation practices is preferred
O que oferecemos?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.