Q.C Finished Product Manager
APEX Pharma
Employer Active
Posted on 30 Oct
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
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.
Desired Candidate Profile
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.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Q.C Finished Product Manager
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