Head of Quality Assurance

Job Description

Title: Head of Quality Assurance

Company Name: Fortune Medical System Limited

Vacancy: 1

Age: 32 to 45 years

Job Location: Dhaka, Gazipur (Sreepur)

Salary: Negotiable

Experience:

• 8 to 10 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Medical Equipment

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

• 8 to 10 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Medical Equipment

• Age 32 to 45 years
• Only Male

Job Summary:

We are looking for experienced and detail-oriented persons for its pharmaceutical & medical device manufacturing plants. The ideal candidates must have good knowledge in Quality Systems, Regulatory Affairs, Product Development of pharmaceuticals, biosimilar products and medical devices.

Key Responsibilities:

• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with DGDA & international standards like WHO, PICs, EU, UD-FDA, (ISO 13485 & MDR for medical device).

• Ensure all pharmaceutical, biosimilar products and medical device meet quality and regulatory requirements prior to release.

• Supervise product registration and regulatory submissions.

• Lead internal and external audits, including regulatory inspections.

• Handle documentation control, deviation, CAPA, change control, and risk management processes.

• Coordinate with production, engineering, QC, and R&D teams to ensure quality compliance.

• Prepare and review batch manufacturing documents, SOPs, validation protocols, and reports.

• Oversee quality control activities, environmental monitoring, stability studies, validation & qualifications, calibration, preventing maintenance activities.

• Coordinate training activities.

Educational Requirements:

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biochemistry, or a relevant field.

Experience Requirements:

• Minimum 8-10 years of experience in a pharmaceutical/medical device manufacturing company.

• At least 2–3 years in a leadership role.

• Strong experience in Regulatory Affairs is mandatory.

• Experience in pharmaceutical & biosimilar/medical device testing is required.

• Experience in contract manufacturing will be an added advantage.

Required Skills:

• In-depth knowledge of GMP, WHO GMP, PICs, EU & US-FDA, (MDR & ISO 13485 for medical device).

• Strong understanding of pharmaceutical and biosimilar/medical device regulatory requirements.

• Experience in handling regulatory audits and inspections (DGDA and international).

• Strong knowledge of validation (IQ/OQ/PQ), process validation, method validation, and cleaning validation.

• Knowledge of ICH stability guidelines and stability data analysis.