This document provides the job description for Md. Khalid Hossain, Assistant Manager of Quality Assurance at BEXIMCO PHARMACEUTICALS LIMITED. His responsibilities include monitoring GMP compliance during production, reviewing batch records, conducting training, checking production records, sampling products, operational support for validation activities, managing quality assurance inventories, analyzing samples, ensuring proper labeling, preparing calibration plans and lists, calibrating instruments, drafting SOPs and plans, and ensuring samples are provided to quality control on time. He reports to the Executive Director of Quality and has no direct reports.
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Job Description (KHD)
1. BEXIMCO PHARMACEUTICALS LIMITED
TONGI - 1711, GAZIPUR, BANGLADESH
JOB DESCRIPTION
Name of the employee: Md. Khalid Hossain
Qualification: MBA, M.Sc. (Biochemistry) Designation: Assistant Manager,QA
Department: Quality Assurance Experience: 08 years and 08 Months
Date of Joining: 31/08/2006 Employee code: 08593
Reporting To: Executive Director, Quality Span of Control: Nil
Responsibility
ï‚· To monitoring of GMP at various stages of Production to meet the regulatory requirements.
ï‚· Online review of Batch Production records.
ï‚· Conduct training for incumbent of QA department related to IPQA system.
ï‚· To check temperature, Humidity & Pressure differential records/charts and other operational
records in production area.
ï‚· In-process inspection, line clearance and sampling of products (Intermediate and Finished stage).
ï‚· Operational support & co-ordination to IPQA activities, process validation, cleaning validation &
any other validation, relevant SOPs meeting cGMP and regulatory requirements.
ï‚· Requisition and management of inventory and other necessary support to maintain the GDP of QA
department.
ï‚· Analysis of in-process quality assurance sample.
ï‚· To check proper labeling of the product container and status labeling of equipment and area.
ï‚· Preparation of calibration master list, calibration master plan before beginning of each year and
when required.
ï‚· Calibration of all IPQA instruments as per Calibration Master Plan.
ï‚· Preparation of QA SOPs, Calibration Master Plan, In-process Sampling Plan etc.
ï‚· Ensure the update of all IPQA specifications, sampling plan & ensure supply of all IPQA
intermediate, finished, control & stability sample to QC on time.
ï‚· Any additional responsibilities as per the work requirement of the department from time to time.
I accept
Name/Signature Date :
Head of Department
FRM No.: FTR/002-03