QA Manager

Job Description

Title: QA Manager

Company Name: Ambee Pharmaceuticals Ltd

Vacancy: 1

Age: At least 45 years

Job Location: Dhaka

Salary: --

Experience:

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

1. Master’s degree in Pharmacy.

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

• Age At least 45 years

1. Extensive experience in quality assurance within the pharmaceutical industry.
2. In-depth knowledge of GMP, GLP, and other regulatory requirements.
3. Strong leadership and team management skills.
4. Excellent analytical, problem-solving, and decision-making abilities.
5. Effective communication and interpersonal skills.
6. Proficiency in quality management software and tools.

The applicants must have experience in the following business area(s):

1. Quality Control testing of raw materials, in-processing samples, finished
2. products using analytical techniques, dissolution testing, and other relevant
3. methods.
4. Analytical Method Development/validation and method transfer activities
5. including protocol development execution and documentation. Stability testing programs
6. Analytical work, Analytical Instruments such as HPLC, UV, FTIR, AAS, GC and TOC.

1. Develop, implement, and maintain the Quality Management System (QMS) in compliance with regulatory requirements.
2. Stay current with national and international regulations and standards relevant to pharmaceutical manufacturing, ensure compliance of company products with regulatory requirements, and prepare for and manage regulatory inspections and audits.
3. Oversee quality control (QC) processes to ensure compliance with quality specifications for raw materials, intermediate products, and final products, including approving specifications, test methods, and standard operating procedures (SOPs).
4. Ensure proper documentation and record-keeping practices are followed, including overseeing the preparation, review, and approval of quality-related documents.
5. Develop and implement training programs for QA and production staff on quality standards, procedures, and regulatory requirements.
6. Plan and conduct internal audits to ensure QMS compliance, identify areas for improvement, and manage the corrective and preventive action (CAPA) process to address audit findings.
7. Evaluate and monitor the quality performance of suppliers and contract manufacturers, conducting supplier audits to ensure compliance with the company`s quality standards.
8. Lead quality improvement initiatives to enhance product quality, process efficiency, and cost-effectiveness while implementing and monitoring key performance indicators (KPIs) for quality performance.
9. Oversee the batch release process to ensure compliance with required quality standards, approving or rejecting products based on quality review and test results.
10. Work closely with production, R&D, supply chain, and other departments to seamlessly integrate quality requirements, and participate in cross-functional teams for new product development and process improvement projects.