Description
Essential functions:- Perform batch record review activities for products ensuring that they meet specifications and are produced and tested in compliance with approved procedures and regulations.
- Compile, organize and file quality records and documentation which include executed batch record documentation, manufacturing records, analytical data package, and labeling and packaging records, and associated documentation.
- Review analytical/stability data and trend.
- Generate key quality performance indicators, collect metrics and perform data trending analysis.
- Participate and support internal audits, external audits and regulatory inspections.
- Assist in quality investigations of GMP activities, generate incident reports, change controls and CAPA reports.
- Develop and revise standard operating procedures, specifications, validation procedures, work instructions and forms as needed.
- Develop and implement methods and procedures for monitoring work activities Special project as required supporting departmental goals
Desired Skills and Experience:
- The ability to collaborate successfully and build relationships with internal teams, suppliers and agencies is required.
- Must have strong computer skills, Microsoft office programs (Word, Excel, PowerPoint, Outlook, etc.)
- A Bachelor's degree is required. Must have a minimum of 6+ years biopharmaceutical experience with small molecules.
To find out more about Real please visit www.realstaffing.com