Manager, Quality Assurance

BDT(Tk)  Negotiable Full time on site
Manager, Quality Assurance
Job Description

Requirements

Education
  • Masters, Bachelor/Honors

M.Pharm/B.Pharm having Pharmacy Council registration

Experience
  • At least 10 years
  • The applicants should have experience in the following business area(s):
    Pharmaceutical/Medicine Companies
Additional Requirements
  • Age at most 40 years
  • Having good communication skill both in English and Bangla

  • Good computer knowledge.

  • At least 10 years experience in reputed pharmaceutical company (s) out of which 2-3 years in similar position will be preferred


Responsibilities & Context

A leading pharmaceutical company manufacturing and marketing a wide range of quality products, is looking for a dynamic person to provide leadership and strengthen its existing Quality Assurance team.

Major Duties & Job responsibilities:

  • Implement all quality functions of the Pharmaceutical Manufacturing Plant

  • Prepare and revise quality documents, this includes Site Master File, Quality Policy, Quality manual, Validation Policy & Documents, Validation Master Plan, Calibration master plan, Training manual, SOPs etc.

  • Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulatory guidelines, company procedures and policies

  • To monitor calibration process of monitoring and measuring equipment, calibration. schedule and relevant documentation.

  • Coordination and execution BMR and BPR approval & issue of BMR and BPR for production

  • Coordinate and execute all the validation, qualification and technology transfer activities

  • To check and monitor that DQ, IQ, OQ & PQ of facilities, equipment and utilities are performed and documented as per regulatory requirements

  • To implement and maintain of ISO 9001 : 2015 QMS

  • Acts as a quality liaison with regulatory authorities, ISO 9001 : 2015 QMS inspectors, and external auditors during inspections

  • Oversee the nonconforming product, market complaint, product recall, change control, deviation procedure, release, rejection, annual product quality review (APQR) vendor qualification and corrective and preventive actions.

  • Co-ordination with other department to enhance and implement company's Quality Management System.


Employment Status

Full Time

Job Location

Anywhere in Bangladesh

Job Highlights

At least 5 years of either M&A or project finance / structured finance experience specializing in Power Generation / Oil & Gas sectors.