Sr. Executive (QA)

Job Description

Title: Sr. Executive (QA)

Company Name: Osman Group of Industries

Vacancy: 01

Job Location: Gazipur

Employment Status: Full-time

Educational Requirements:
∎ M.Pharm from any reputed University.

Experience Requirements:
∎ 5 to 7 year(s)

Job Responsibilities:
∎ Monitor dispensing of raw materials as well as manufacturing & packaging processes in compliance with GMP
∎ Perform IPQA, BMR-BPR checking, change control activities and batch release activities.
∎ Prepare and control of SOPs and ensure QMS related documentation.
∎ Handle the market compliant, deviation, QIR, CAPA, NCR & rejections.
∎ Handle the batch document & retention sample and ensure proper investigation of quality incidents
∎ Design, develop, implementation, monitoring and controlling overall documentation system as per the cGMP requirements.
∎ Generating all the required documents for production i.e. Manufacturing Order (MO), Batch Manufacturing Record (BMR) and Batch Packing Record (BPR).
∎ Controlling and distributing the SOPs, Log Books of all departments.
∎ Ensuring required initial and continuous training of production/plant personnel is carried out and adapting according to the need.
∎ Preparing DQ, IQ, OQ and PQ protocols.
∎ Preparing report of IQ, OQ, PQ of equipment, utility and facility.
∎ Providing technical validation support to project and production teams.
∎ Preparing and Compilation Cleaning Validation / Process Validation / Media Fill Validation Protocol/ Reports.
∎ Preparation of Validation Master Plan, Site Master File, Quality manual, Training manual, etc.

Additional Requirements:
∎ Knowledge on GMP, Validation, Drug Rules & Regulations.
∎ Ability to work under pressure. Good Computer literacy (like MS office, Adobe Illustrator). Strong communication skill.
∎ Experience should be same area in any reputed Pharmaceuticals company.

Salary: Negotiable

Application Deadline: September 27, 2019

Company Information:
∎ Osman Group of Industries

Category: Production/Operation