1. DUTIES & RESPONSIBILITIES

• Authorized Personnel who approves or rejects starting materials, packaging materials, and intermediate, bulk and finished products in relation to their specification;
• Ensures that products are sold or supplied after certification that each production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of medicinal products;
• Ensures that all necessary testing is carried out and the associated records evaluated;
• Approves, authorizes and controls quality documentation system; sampling instructions, specifications, test methods and other QC procedures; 
• Checks the maintenance of the department, premises and equipment;
• Ensures the appropriate validations, including those of analytical procedures, and calibrations of control equipment are carried out;
• Ensures that the required initial and continuing training of quality unit personnel is carried out and adapted according to need;
• Establishes, implements and maintains of the quality system;
• Supervises the regular internal audits or self-inspection;
• Participates in external audit (vendor audit);
• Supervises and monitors handling of deviation during processing and out-of-specification results;
• Supervises the monitoring and control of manufacturing enviroment (plant hygience, environmental requirement…);
• Supervises the handling, storage and dispense material, packaging material and finished pharmaceutical product;
• Conducts new supplier evaluation and perform assessment for approved suppliers;
• Supervises the qualification, calibration, maintenance programme of equipment;
• Supervises the compliance with SOPs, GxP guidelines and Marketing Authorization;
• Ensures proper inspection, investigation, and taking of samples in order to monitor factors which may affect product quality.

2. QUALIFICATIONS

• Graduated in Pharmacy;
• Minimum 10 years of supervisory experience of multiple staff members and teams;
• Has experience on department management in pharmaceutical companies, experience on QA documentation system, paper and computerized;
• Participated in GxP inspections of pharmaceutical companies or held positions related to the preparation for the GxP inspection and obtain GxP certificates;
• Has experience in quality management, ensures that the finished pharmaceutical products complies with martket authorization.

3. SKILLS

• Has ability to manage and direct personnel of the department;
• Competent in quality assurance management;
• Ability to make decisions and implement changes as directed;
• Must have good written and verbal communication skills and ability to work with all levels of the organization;
• Computer knowledge of data collection systems, spreadsheet software, Microsoft Word, Excel and PowerPoint;
• Effective skills: organization, planning, problem solving, technical and verbal skills.

4. BENEFITS

• 13th month salary & commission;
• ESOP for perennial employee;
• 12 annual leaves;
• Lunch at the Company;
• Company bus from District 1;
• Insurance under Labor Laws.

5. CONTACTS

thuyvy.la@nanogenpharma.com (Ms Vy)