What are the responsibilities and job description for the Administrative Assistant position at Planet Pharma?
This position is responsible for ensuring the document control and training systems are maintained and functioning in compliance with the company's procedures and external standards and regulations. In addition to QA responsibilities, there will be other activities required that support Production and Product Development as needed.
Document Control
- Managing the archival room and sending documentation offsite to Iron Mountain
- Receive and archive / file executed quality-related documentation and records (physical records) in a secure documentation area onsite and offsite—control access to onsite documentation area(s) and track document and record submission and removal activities.
- Support in creating, assigning numbers to, and tracking the issuance, closure, and reconciliation of logbooks and laboratory notebooks. Maintain and archive quality logbooks, as required, in accordance with appropriate procedures.
- Administering the approved Document Control database system.
- Provide support to all personnel for document control
- Creating reports in the approved system for Management Review, Trending requests, etc.
- Maintaining the document control and training modules within the approved system
- Addressing quality system gaps within the document control system stemming from audits. Training
- Administering the approvedTraining database.
- Provide support to all personnel for training
- Monitor the status of the training process
- Provide reports on the status of training
- Coordinate group training when needed Design History Files
- Working with project managers on compiling and maintaining the DHFs. Other Duties
- Other duties as assigned
Experience
