Document Error Reduction SME (closed)
Contract Position-26 months
Send resumes to: firstname.lastname@example.org
Job Description/Major Respnsiblities:
• The Document Error Reduction SME for Home Office will provide leadership and coordination for the entire Document Error Reduction project for the Companyl Cosent Decree. The Document Error Reduction program will include a Company-wide training program and formatting improvements for documents to be executed on paper.
• Indivdually develops or sources from an external organization a comprehensive training program for all Company employees who execute GMP documentation, targeting different types of training to different audiences (e.g. shop floor employees who document GMP actions on batch records and forms, lab employees who document GMP activities in laboratory notebooks, and office-based employees who document GMP activities in protocols, reports, and other forms).
• Implements the training program across Company• Monitors the effectiveness of the training proram and makes adjustments, as necessary.
• Partners with the Document Control group.
• The Documentation Error Reduction SME will perform the assigned tasks as per the established procedures to ensure compliance to Companies requirements.
A minimum of a Bachelors degree is required.
• Prior experience in a pharmaceutical GMP environment is required (minimum 10 years).
• Prior experience with reducting GMP documentation errors is required (minimum 2 years).
• Prior shop floor experience in a pharmaceutical GMP manufacturing environment is preferred.
• Prior experience developing and/or delivering GMP documentation error reduction training is preferred.
Thorough knowledge of FDA, EMA, and cGMP regulations is required. Strong computer skills, proficient in Word and Excel. Ability to communicate effectively with all levels. Strong teamwork and collaborative skills. Excellent written and verbal communication skills. Strong organizational skills.