Manager, Quality Assurance - Product Development
HALO Pharmaceutical Inc. - Whippany, NJ

This job posting is no longer available on HALO Pharmaceutical Inc.. Find similar jobs: Manager jobs - HALO Pharmaceutical jobs

This position supervises the daily QA function of the QA inspection group and activities related to drug product development.

Responsibilities:

QA INSPECTION
  • 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
    problem-solving issues.
  • Monitor and coordinate retest sampling with QC lab
  • Maintain annual packaged product inspection program (retains)
  • Support product complaint inspection and investigation.

PRODUCT DEVELOPMENT
  • 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.

Qualifications:
  • 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. - 17 months ago - save job - block
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