A global pharmaceutical company looking to add a Senior Compliance Associate to their team. This individual will be responsible for providing scientific support in the root cause analysis and closure of OOS investigations, OOT investigations, and product quality complaints.
- Work closely on technical investigations relating to Product Quality Complaints
- Participate in other quality investigations and risk assessments as requested to perform review of documents, SOPs, processes, testing, etc.
- Manage electronic Quality Management System (TrackWise) as well as Implement electronic Quality Systems (eQMS, EDMS, and LMS)
- Develop presentations monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
- Follow up with stake holders for closures of all open QMS documents and update TW accordingly
- Improve QMS compliance through newly initiated programs
- 6-8 years related experience in a pharmaceutical manufacturing environment
- Working knowledge of cGMPs, GLPs SAP, EDMS, LMS, Master Control etc.
- Strong knowledge of Trackwise
- Strong knowledge of instrumental and wet analytical chemistry and microbiology testing
- Experience with the manufacture and testing of radiopharmaceuticals
- Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacturing