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QC Finished Product Manager

APEX Pharma
Badr City, Cairo
APEX Pharma logo

QC Finished Product Manager

Badr City, Cairoposted 1 month ago
70Applicants for1 open position
  • 0Viewed
  • 0In Consideration
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Job Details

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Job Description

  • Review of all results of the finished product.
  • Review all standard operating procedures for finished products
  • Check instruments logbooks, audit trail, COAs, and SOPs
  • Maintain and follow up on finished product retained samples store.
  • Check performance for finished product staff.
  • Reporting deviations, suspect results, OOS results, and any other required reports
  • Review all Standard operating procedures for the finished product.
  • Check instruments/ equipment logbook, audit trail, analyst logbook, results of analysis, COA & SOPs.
  • Review concern instrumental analysis using HPLC, Gas chromatographs, UV ⁃ Vis Spectrophotometer, IR spectrophotometer, and Atomic Absorption Spectrophotometer, and other minor analytical equipment after having the necessary Training.
  • Review the preparation of chemical reagents and other required volumetric solutions as directed.
  • Reporting deviation, suspect results, out-of-specification results, and any other Required reports.
  • Reply to audit points concerning the finish lab.

Job Requirements

  • Bachelor's degree of Pharmacy or Science.
  • 12 years of experience in the same role at reputable Pharmaceutical companies.
  • Well-trained in QC laboratories (Pharmaceutical company).
  • Strong background in finished product analysis of different dosage forms (tablets, capsules, semisolids)
  • Experience with method validation and instrument qualification.
  • Strong background in GMP, GLP, and ISO17025 principles
  • OOS/OOT, deviation investigation, and CAPA handling
  • Having a background in chemical and physical analysis.
  • Familiar with instrumental analysis using HPLC, gas chromatographs, UV – VIS spectrophotometer, IR spectrophotometer, atomic absorption spectrophotometer, and other minor analytical equipment.
  • Familiar with the documentation system in the laboratory
  • Complying with the applicable GMP standard and procedures.
  • Familiar with handling of deviation, suspect results, out-of-specification results, and any other required reports.
  • Excellent Leadership and Managerial skills.
  • Effective Communication skills.
  • Ability to prioritize activities, to make difficult decisions to ensure efficient use of resources, and address critical issues impacting the business.
  • Strategic thinking and planning skills.

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