This position supervises the daily QA function of the QA inspection group and activities related to drug product development.
- Supervise QA Inspectors in the day-to-day quality control operations including:
- Sampling and inspection of raw materials, labeling/packaging components and drug products.
- Administer hold system for raw materials, components, API, etc.
- In-process/packaged product audits.
- Releasing/rejecting materials/drug products in computerized inventory system.
- Provide workload prioritizations and scheduling determinations.
- Provide assistance as needed to the QA inspection group relative to troubleshooting and
- Monitor and coordinate retest sampling with QC lab
- Maintain annual packaged product inspection program (retains)
- Support product complaint inspection and investigation.
- Participate in PD planning meetings and teleconferences
- Assist in investigations and deviations.
- Review/ approve (or if needed write) protocols and reports as required.
- Review and approval of PD related GMP documents including, but not limited to specifications, methods, batch records, etc., as required.
- B.S. degree (pharmacy, chemistry or natural science preferred)
- 5+ years in quality control/assurance experience in the pharmaceutical industry; (minimum of 2 years of supervisory/lead role experience preferred).
- Essential knowledge of quality assurance procedures, cGMP and batch records.
- Working computer knowledge; (familiarity in SAP R/3, TrackWise a plus).
- Strong communication and interpersonal skills.
- Effective leadership skills.
- Knowledge of pharmaceutical development activities a plus.
HALO Pharmaceutical Inc. - 13 months ago