The company is looking to solve the problem of ensuring adherence to Standard Operation Procedures and current Good Manufacturing Practices in the release of semi-finished and finished drug products.
Requirements
- Intermediate Microsoft Word and Microsoft Excel skills.
- SAP experience preferred.
- Working knowledge of Quality Assurance systems, cGMP’s, ISO 13485, CMDRs, and EMEA regulations preferred.
- Competency utilizing Electronic Systems ie. Maximo and Trackwise. for Quality checks
- Experience with GMP Environment.
- Experience in an aseptic manufacturing environment preferred.
Responsibilities
- Performing the Quality Assurance review and release of semi-finished product, validation, media, and final products.
- Review batch records to support product release schedule, ensuring regulatory compliance, customer satisfaction and delivery of products.
- Quarantine and monitor product in “on hold” status prior to disposition.
- Prepare required batch disposition documentation and provide to international markets as required to ensure current Good Manufacturing Practices compliance.
- Identify and resolve all batch record discrepancies to prevent a regulatory impact.
- Perform all Final Product and disposition. Following global and SOPs for release in SAP.
- Performing the Quality Assurance check of all batch related documents for manufacturing, production, validation, and quality assurance departments.
Other
- Bachelor’s Degree in the Sciences or technical field or equivalent experience.
- 5 years of experience in a quality role or experience handling and reviewing documentation records.
- 3 years of experience in a GMP Environment.
- Ability to exercise independent judgement and critical thinking.
- Travel requirements not specified
