Manufacturing Documentation Specialist

4 days ago


Arnprior, Canada Pillar5 Pharma Full time

The Documentation Specialist is an internal resource who ensures all production documentation complies with all relevant requirements - internal, customer, and regulatory. As a member of the APA team, the Documentation Specialist will liaise with Equipment Operators, Team Leads, and members of the Quality organization to ensure the production of high quality documentation.

**Responsibilities**:

- Assist with the editing of quality documents (SOPs, guidelines, validation master plans etc.) to ensure compliance with regulatory requirements.
- Work closely with Operations leadership to identify areas to improve documentation - review current processes, tools, and methodologies with a critical towards improving and streamlining documentation processes and outputs.
- Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation.
- Provide internal guidance and training to Operations team on documentation requirements, processes, and SOPs.
- Translate business specifications into user documentation - specifically ensuring all SOPs are clearly written and meet business requirements.
- Track and review change control documentation.
- Authors deviations and CAPAs for Manufacturing and participates and applies Root Cause Analysis (RCA) tools and ensures CAPAs are implemented to eliminate deviation re-occurrence
- Plan, write, and maintain systems and user support documentation efforts to ensure RFT principles are applied across all Operations documentation.
- Provide planning oversight to project team from new equipment introduction to commercial readiness.

**Qualifications**:

- Relevant degree/diploma is an asset
- Must be able to work quickly with a high degree of accuracy.
- Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
- Proven experience reviewing manufacturing, engineering, or quality documentation
- Demonstrated background authoring CAPAs and deviations in a GMP environment
- Knowledge of FDA and HC regulatory requirements are an asset.
- Experience with FAT/SAT/DQ/IQ/OQ



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