Executive - Quality Assurance (QA)

Job Description

Title: Executive - Quality Assurance (QA)

Company Name: Amico Laboratories Limited

Vacancy: 1

Age: At least 27 years

Job Location: Dhaka (Savar)

Salary: --

Experience:

• At least 1 year
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Bachelor of Pharmacy (B.Pharm)

• Bachelor of Pharmacy (B. Pharm) from a recognized university.

• Master of Pharmacy (M. Pharm) will be preferred.

• At least 1 year
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Age At least 27 years

• 1 to 2 years of relevant experience in Quality Assurance (QA) in a pharmaceutical manufacturing company.

• Practical experience in GMP, batch documentation and QA activities will be preferred.

Job Location: Factory, Khagan, Savar, Dhaka

Key Responsibilities

• Perform In-Process Checks (IPC) and review Batch Manufacturing Records (BMR) and Hold/Process Records (HPR).

• Handle Change Control activities and support Batch Release processes.

• Handle Market Complaints, Deviations, Quality Incident Reports (QIR), Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR) and product rejection activities.

• Review and maintain batch documentation and retention samples and ensure proper investigation and documentation of quality incidents.

• Conduct Training Needs Assessments (TNA) and assist in preparing and conducting training programs for employees.

• Issue, review and close Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) and perform final product release activities for the market.

• Issue, review and approve Process Validation and Hold Time Study protocols and monitor validation activities.

• Issue, review and approve Machine/Equipment Qualification protocols and monitor qualification and requalification activities.

• Ensure proper preparation, review, maintenance and control of all Quality Assurance-related documents in accordance with applicable SOPs, GMP requirements and the Quality Management System (QMS).

• Ensure compliance with established quality standards, SOPs and applicable regulatory requirements.

• Coordinate with Production, Quality Control and other relevant departments to ensure effective implementation of the Quality Management System.

• As per Company Policy.