Join Lupin's U.S. team and become part of an organization that encourages professional development and innovation! We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin’s Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus.
Requirements
- Sample, inspect incoming raw materials, components, in-process, intermediates, and finished products and submits samples to the QC laboratory for analysis.
- Inspect the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them for use before the start of the operation
- Perform QA in-process checks (Beginning, Middle and End) for manufacturing/packaging operations and determine the results meets against pre-determined standards and batch record
- Conduct AQL inspections on incoming materials and finished dosage forms against pre-determined Quality attributes.
- Collect and maintain QA Retain samples from all products manufactured. Assure that all retains are stored appropriately for accountability, annual inspection
- Sample and proofread all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for use.
- Inform immediately any manufacturing/packaging issue to the QA supervisor
- Assure all activities are following the batch records, departmental SOP’s, GMP, and DEA regulations.
- Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation/yields.
- Ensure the proper isolation of rejected or defective product/ material generated during the batch process and accountability in the batch record.
- Monitor facility and product environmental operating conditions.
- Provide necessary support to conduct root cause analysis for any incidents generated at the facility during all phases of the production and packaging process.
- Perform other QA duties as assigned
Benefits
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Generous Paid Time Off
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
