Manager, Quality Assurance (QA)

Job Description

Title: Manager, Quality Assurance (QA)

Company Name: Raysun Biopharma Co., Ltd, Laos

Vacancy: 1

Age: At least 35 years

Job Location: Laos

Salary: Negotiable

Experience:

• At least 8 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Healthcare/Lifestyle product

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

• At least 8 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Healthcare/Lifestyle product

• Age At least 35 years

Experience Requirements

• Minimum 8–10 years of relevant experience in the pharmaceutical industry.
• At least 3–5 years in a managerial position within Quality Assurance.
• Experience in establishing a QA/QMS system from inception will be highly preferred.
• Experience in establishing a QA/QMS system from inception will be highly preferred.
• In-depth knowledge of WHO GMP, US FDA, and EU GMP guidelines.
• Excellent leadership, communication, and documentation skills.
• Strong ability to work under pressure and meet strict regulatory timelines.
• Proficiency in MS Office and quality management software.

Language requirement:

• English: Proficient in Speaking and Writing

RAYSUN BIOPHARMA CO.,LTD Company is a newly established pharmaceutical manufacturer is located in Laos, dedicated to producing high-quality and affordable medicines to serve patients and healthcare providers worldwide.

We are looking for a highly competent and experienced Quality Assurance (QA) Manager to lead and establish our QA operations from the ground up. The selected candidate will be responsible for designing, implementing, and maintaining a robust Quality Management System (QMS) in full compliance with WHO, GMP, US FDA, EMA, and other global regulatory requirements.

Key Responsibilities

• Establish, implement, and maintain an effective Quality Management System (QMS).
• Develop, review, and approve SOPs, policies, and departmental guidelines.
• Ensure GMP compliance in facility layout, HVAC, purified water systems, and cleanroom qualification.
• Oversee all validation activities including process, cleaning, equipment, and analytical method validation.
• Supervise documentation control such as BMR, BPR, CoA, logbooks, and change control systems.
• Approve suppliers and ensure the quality of APIs, excipients, raw materials, and packaging materials.
• Develop and conduct training programs on GMP, GDP, and SOPs for all employees.
• Conduct internal audits and ensure readiness for external regulatory inspections (DGDA, WHO, FDA, EMA, etc.).
• Review and approve batch records for product release.
• Lead, guide, and manage the QA team to foster a culture of quality excellence and continuous improvement.

• Performance bonus,Profit share,Provident fund,Gratuity,Over time allowance,Mobile bill
• Lunch Facilities: Full Subsidize
• Salary Review: Yearly
• Festival Bonus: 2