Manager Quality Assurance - pharmaceutical

Job Description

Title: Manager Quality Assurance - pharmaceutical

Company Name: Promixco Group

Vacancy: Not specific

Job Location: Gazipur

Employment Status: Full-time

Educational Requirements:
∎ Master of Pharmacy (M.Pharm), Master of Science (MSc)

Experience Requirements:
∎ 4 to 5 year(s)
∎ The applicants should have experience in the following area(s): CAPA, Capacity Development, cGMP, Chemical Industries
∎ The applicants should have experience in the following business area(s): HVAC System, Manufacturing (FMCG)

Job Responsibilities:
∎ Routine coordination and quality review of Contract Manufacturer Organization (CMO) Partners' documentation including batch record review for compliance to facilitate timely disposition of product lots.
∎ Quality Systems: Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, QA holds, Deviations, Technical Complaints/Adverse Events, Management Monitoring and Self inspection auditing, QA reporting and approval of GMP documentation.
∎ Quality Operations: Support GMP compliance and inspection readiness within organization.
∎ Reviews records to ensure data meets the industry requirements for data integrity.
∎ Provides Quality oversight over software qualification, calibration and validation.
∎ Ensures that procedures are being followed as outlined under FDA, ISO, USP and CGMP guidelines.
∎ Provides input and quality oversight over investigations, which includes review of investigation reports and associated corrective and preventative action (CAPA) plans.
∎ Partners with Quality team members to implement centralized processes and ensures compliance to industry standards and compendia requirements.
∎ Conducts internal audits and external to determine if work activities affecting quality are in compliance with established quality procedures and that the quality management system is operating effectively.
∎ Participates in qualification and approval of suppliers and subcontractors.
∎ Promotes a quality mindset and quality excellence approach to all activities.
∎ Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process.

Additional Requirements:
∎ Age 35 to 40 years
∎ Only males are allowed to apply
∎ Master of science or M pharm in reputed university, experience in pharmaceutical plant & FMCG Manufacturing Plant

Salary: Negotiable

Compensation & Other Benefits:
∎ T/A, Mobile bill, Tour allowance, Medical allowance, Performance bonus, Profit share
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ As per company Policy

Application Deadline: 29 Jul 2020

Company Information:
∎ 29 Jun 2020
∎ Promixco Group
∎ Address : BGIC Tower (5th Floor), 34 Topkhana Road, Dhaka-1000, Bangladesh.
∎ Web : www.promixcogroup.com

Category: Medical/Pharma