Assistant Manager - QC

Job Description

Title: Assistant Manager - QC

Company Name: Ambee Pharmaceuticals Ltd

Vacancy: --

Age: At least 23 years

Job Location: Anywhere in Bangladesh

Salary: --

Experience:

• At least 5 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Medical Equipment, Herbal Medicine, Healthcare/Lifestyle product

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

• At least 5 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Medical Equipment, Herbal Medicine, Healthcare/Lifestyle product

• Age At least 23 years

• 5 years of practical experience in Pharmaceuticals industry

Job Location: Factory

Job Responsibilities

• Lead and supervise day-to-day QC laboratory operations covering RM, PM, in-process, and FG testing.

• Ensure timely analysis and release/rejection decisions in compliance with approved specifications and pharmacopeial methods (USP/BP/EP).

• Operate, calibrate, and oversee maintenance of major analytical instruments — HPLC, ICP-OES, UV-Vis, dissolution apparatus, and others.

• Review and approve analytical data, COAs, worksheets, and logbooks ensuring ALCOA+ data integrity compliance.

• Manage method validation, method transfer, and verification activities per ICH Q2(R2).

• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviations; drive root cause analysis and CAPA closure.

• Coordinate stability studies as per ICH Q1A(R2) and protocol-driven monitoring schedules.

• Ensure laboratory readiness for DGDA, WHO, and customer audits; address observations and implement corrective actions.

• Manage instrument qualification (DQ/IQ/OQ/PQ), calibration scheduling, and analyst competency development.

• Maintain reference standards, working standards, reagents, and controlled-environment compliance