Manager, Quality Assurance Department

Job Description

Title: Manager, Quality Assurance Department

Company Name: SinoHealth Pharmaceuticals Ltd

Vacancy: 1

Age: 42 to 55 years

Job Location: Gazipur (Gazipur Sadar)

Salary: Negotiable

Experience:

• At least 15 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Master of Science (MSc) in Chemistry, Applied Chemistry, Biochemistry
• Bachelor of Science (BSc) in Chemistry, Applied Chemistry, Biochemistry

• At least 15 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Age 42 to 55 years

• Lead and manage the overall Quality Assurance (QA) function of the pharmaceutical manufacturing facility.

• Ensure compliance with GMP, cGMP, WHO-GMP, GLP, and applicable regulatory requirements.

• Develop, implement, and continuously improve the company’s Quality Management System (QMS).

• Review and approve SOPs, specifications, protocols, reports and other quality documents.

• Ensure proper handling, investigation, and closure of deviations, OOS/OOT, CAPA, Change Control, and Market Complaints.

• Supervise and ensure proper execution of Batch Record review and Batch Release activities.

• Coordinate and lead internal, external, regulatory and customer audits/inspections.

• Ensure proper implementation of Self-Inspection, Quality Risk Management, and Continuous Improvement programs.

• Review and approve Validation/Qualification protocols and reports in coordination with relevant departments.

• Ensure proper documentation, data integrity, and compliance with established quality procedures.

• Monitor manufacturing and packaging operations to ensure compliance with approved procedures and GMP requirements.

• Provide guidance and leadership to QA personnel and develop the team through training and performance management.

• Coordinate effectively with Production, Quality Control, Engineering, Regulatory Affairs, Warehouse, and other relevant departments.

• Identify potential quality risks and implement appropriate preventive and corrective measures.

• Keep management updated regarding significant quality issues, compliance risks, and improvement initiatives.

• Perform any other duties assigned by the management related to Quality Assurance and regulatory compliance.

• Mobile bill
• Salary Review: Yearly
• Festival Bonus: 2
As per company policy.