Overview
Prepare and maintain detailed Manufacturing Batch Records (MBRs), Packaging Batch Records (PBRs), packaging component, protocols and reports. New documents will be developed based on input from Product Development, Operations, Validation, Quality and Project Management. Revisions will be maintained based on detailed and specific changes to the original document as requested by the above departments.
Responsibilities
• Develop new detailed manufacturing and Packaging instructions, based on complex and diverse documents provided by internal and external client technical resources
• Manage and control manufacturing documents during multiple revisions, ensuring accuracy of the original documents and the integrated changes.
• Edit, standardize, and/or make changes to material prepared by other writers.
• Author new and revised specification for packaging components and input in electronic document management system (HEROs)
• Collaborate with SMEs to capture best practices and accurate documentation.
• Organize material and complete writing assignments according to set standards regarding order, clarity, conciseness, style, terminology and SOPs.
• Maintain records and files of work and revisions.
• Recommends changes to the process to enhance efficiencies and improve current processes.
• Become familiar with production processes and methods by building productive relationships with production, engineering, validation and development personnel.
• Observe production, developmental, and experimental activities to understand detailed operating procedures and methods to create effective manufacturing documents.
• Train or assist in the training of new hires.
• Work independently to meet client requirements and strict deadlines.
• Other duties as assigned.
Qualifications
• Accuracy – Ability to perform work accurately and thoroughly.
• Adaptability – Ability to adapt to change in the workplace.
• Communication – Strong oral and writing skills, including effective listening.
• Detail Oriented – Ability to pay attention to the minute details of a record or task.
• Organized – Possessing the trait of being self-motivated and following a systematic method of performing a task.
• Proficiency in Microsoft Word and Excel.
• Proficiency in electronic Document Management systems desired.
• Relationship Building – Ability to effectively build relationships with internal and external customers.
• Client Oriented – Ability to take care of the clients’ needs while following company procedures.
EDUCATION:
Bachelor’s Degree (four year university)
EXPERIENCE:
• Two to four years related experience, preferably in Contract Pharmaceutical Manufacturing utilizing Documentum
• Experience in a Pharmaceutical Manufacturing Operating environment
• Experience in batch record preparation and report writing