Job Description

Title: Deputy Manager/Manager, Quality Assurance

Company Name: RRP Pharmaceutical

Vacancy: 1

Age: 35 to 45 years

Location: Pabna (Ishwardi)

Salary: Negotiable

Experience:
∎ 10 to 12 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies

Published: 10 Mar 2025

Education:
∎ Master of Pharmacy (M.Pharm)

Requirements:

Additional Requirements:
∎ Age 35 to 45 years
∎

Responsibilities & Context:
∎ Ensure implementation of cGMP according to EU GMP, MHRA, TGA, and WHO guidelines.
∎ Regular monitoring of regulatory updates and implementation of current requirements.
∎ Review and approve investigation reports, deviations, customer complaints, OOS, vendor selection, Change Control, CAPA, APQR, and Recall.
∎ Conduct quality risk management using FMEA for machines, equipment, processes, systems, and procedures.
∎ Ensure qualification and validation of equipment, instruments, and systems per validation master plan.
∎ Prepare and review QMS documentation per regulatory guidelines (WHO, ICH, PIC/S, local regulations).
∎ Handle local and international regulatory audits.
∎ Review and approve specifications and testing methods in quality control and microbiology labs.
∎ Ensure timely execution of Change Control, CAPA, and preventive actions.
∎ Identify and communicate quality system gaps, revising procedures accordingly.
∎ Review and approve Method Validation Protocols, Method Validation Reports, Technology Transfer Certificates, WTP validation, and Method Verification Reports.
∎ Perform on-line checking of BMR/BPR and batch document compilation for product release.
∎ Prepare and review SOPs, validation/qualification protocols, and related reports.
∎ Investigate and track CAPA for deviations, QIR, OOS, customer complaints, and rejections.
∎ Conduct internal audits, self-inspections, vendor audits, and Annual Product Quality Reviews.
∎ Manage document archiving, retrieval, and disposal per GMP compliance.
∎ Ensure implementation of cGMP according to EU GMP, MHRA, TGA, and WHO guidelines.
∎ Regular monitoring of regulatory updates and implementation of current requirements.
∎ Review and approve investigation reports, deviations, customer complaints, OOS, vendor selection, Change Control, CAPA, APQR, and Recall.
∎ Conduct quality risk management using FMEA for machines, equipment, processes, systems, and procedures.
∎ Ensure qualification and validation of equipment, instruments, and systems per validation master plan.
∎ Prepare and review QMS documentation per regulatory guidelines (WHO, ICH, PIC/S, local regulations).
∎ Handle local and international regulatory audits.
∎ Review and approve specifications and testing methods in quality control and microbiology labs.
∎ Ensure timely execution of Change Control, CAPA, and preventive actions.
∎ Identify and communicate quality system gaps, revising procedures accordingly.
∎ Review and approve Method Validation Protocols, Method Validation Reports, Technology Transfer Certificates, WTP validation, and Method Verification Reports.
∎ Perform on-line checking of BMR/BPR and batch document compilation for product release.
∎ Prepare and review SOPs, validation/qualification protocols, and related reports.
∎ Investigate and track CAPA for deviations, QIR, OOS, customer complaints, and rejections.
∎ Conduct internal audits, self-inspections, vendor audits, and Annual Product Quality Reviews.
∎ Manage document archiving, retrieval, and disposal per GMP compliance.

Skills & Expertise:

Workplace:
∎ Work at office

Employment Status: Full Time

Gender:
∎ Only Male

Job Location: Pabna (Ishwardi)

Company Information:
∎ RRP Pharmaceutical

Read Before Apply: Please apply only who are fulfilling all the requirements of this job

Application Deadline: 21 Mar 2025

Category: Others