Manager, Quality Assurance

Job Description

Title: Manager, Quality Assurance

Company Name: A Leading Pharmaceutical Company

Vacancy: --

Age: at most 40 years

Location: Anywhere in Bangladesh

Salary: Negotiable

Experience:
∎ At least 10 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies

Published: 12 Feb 2025

Education:
∎ Masters, Bachelor/Honors
∎ M.Pharm/B.Pharm having Pharmacy Council registration

Requirements:

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
∎ 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:
∎ 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.
∎ 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

Read Before Apply:

Interested candidates are requested to apply with a detailed resume, passport size photograph, photocopy of national ID card, contact phone number and photocopies of all certificates to https://cutt.ly/pharmaceuticalsfactory within 20 February 2025.