What are the responsibilities and job description for the QA Associate II - PR position at Aveva Drug Delivery Systems?
Description
- Review, approve, and release manufacturing, packaging, and clinical batch records along with auxiliary documentation. Prepare product release summaries and create Certificates of Analysis/Certificates of Compliance as applicable.
- Review and compare laboratory test results to the official specifications and prepare product release documentation/summaries.
- Ensure that batch releases at Aveva are performed in accordance with current approved Standard Operating Procedures (SOPs), and confirm that all supporting documents are received and compliant before release. Resolve any non-conformances prior to release.
- Report and approve all deviations in manufacturing, packaging, and quality control per the SOPs, assessing the impact on the market release of the product.
- Conduct Enterprise Resource Planning (ERP) transactions as part of the release procedure.
- Attend scheduling meetings to coordinate material release priorities as needed.
- Communicate any potential delays in the release of materials and batches for manufacturing, R&D, or commercial distribution.
- Assist with investigation reports and Corrective and Preventive Actions (CAPA) in the Quality Management System (QMS) and participate in special projects as required.
- Write reports and correspondence effectively.
- Collaborate as a team member to achieve all outcomes.
- Demonstrate a good command of the English language, both written and verbal.
- Exhibit excellent organizational skills and effectively manage time.
- Follow instructions according to written procedures and manage multiple priorities in a fast-paced and changing environment.
- Operate in accordance with the company's Code of Conduct and Business Ethics, as well as all established regulatory, compliance, and safety requirements.
- Perform other duties as assigned by the manager.
- B.A. / B.S. degree and a minimum of four years of related experience or six to eight years of related experience. Must be familiar with overall pharmaceutical manufacturing and quality systems/processes.