Job decriptions:
1. Drafting/Reviewing Documents (80%):
- Responsible for drafting/reviewing documents such as SOPs, standards, testing procedures, analytical data sheets, trend analysis, risk assessments, etc.
- Participate in the development of URS, operating and cleaning procedures, calibration/validation/evaluation documents, maintenance, and monitor the validation and calibration status of equipment.
- Participate in drafting the analytical method validation protocol and execute the analytical method validation according to the established protocol.
- Participate in drafting the stability protocol and evaluate and monitor the stability samples of products under research.
- Test raw materials, intermediates, semi-finished and finished products during the drug development process.
2. Other Works (20%):
- Perform tasks as instructed and report directly to the QC department head.
- Execute other tasks as assigned by the QC department head.
Job requirements:
1. Qualifications and Education:
- Bachelor's degree in Pharmacy, Bachelor (Technology) in Chemistry, or Engineer (Technology) in Chemistry.
2. Experience and Professional Knowledge:
- Candidates must have at least 2 years of experience in pharmaceutical manufacturing plants, as well as setting up initial systems for Microbiology laboratories, especially EU-GMP plants.
3. Skills and Qualities:
- English: Proficient in reading and understanding pharmaceutical documents, good communication and writing skills.
- Computer Skills: Effectively use office software including Word, Excel, PowerPoint.
- Others: Proactive in work, self-learning, and friendly with colleagues.

Job decriptions:
1. Role in research and development activities (40%)
- Developing research and development plans and ensuring product quality throughout the product lifecycle, applicable to the following product groups: (i) Solid dosage forms (tablets, hard capsules, sachets); (ii) Liquid dosage forms (syrups, suspensions); (iii) Injectable dosage forms.
- Ensuring product development projects are executed on schedule.
- Reviewing and approving research dossiers.
2. Role in drug registration activities (20%)
- Checking and approving content related to formulas, processes, and production in registration dossiers before transferring them to the drug registration department.
- Coordinating with the RA department to ensure the drug registration plan is on track.
3. Role in the technology transfer process (20%)
- Ensuring the transfer process of products from RD to production, or the transfer process from external units, complies with GMP WHO/EU regulations (including activities related to process validation and method validation).
4. Role in managing RD department activities (10%)
- Assigning work, organizing implementation according to the areas of responsibility.
- Supervising, evaluating, and adjusting activities with department staff within the department's scope of activities.
- Periodically reporting on work effectiveness as per regulations.
- Proposing, developing, and reviewing operational procedures related to the department.
5. Other tasks (10%)
- Performing other tasks as assigned by the Advisory Board and Executive Board.
Job requirements:
1. Qualifications and Education
- Minimum: Bachelor's degree in Pharmacy.
2. Experience and Professional Knowledge
- Minimum 3 years of experience in a managerial position (department head and/or deputy head) or at least 7 years of experience in research and development.
- Professional knowledge: In-depth understanding of legal regulations, quality standards in the pharmaceutical industry, and new trends in pharmaceutical research and development.
3. Skills and Qualities
- English: proficient (4 skills).
- Work and time management skills.
- Analytical, strategic thinking, and risk management abilities.
- Problem-solving and analytical skills.

Job decriptions:
1. Supplier Management (70%)
- Coordinating the evaluation activities of external suppliers of goods and services and preparing evaluation reports.
- Monitoring and updating the status of supplier evaluations.
- Drafting and reviewing quality contracts.
- Conducting onsite supplier audits and preparing audit reports as required.
- Participating in the investigation of non-conforming raw materials and making complaints to manufacturers.
- Reviewing and monitoring the supply chain standards of active ingredients and excipients.
- Conducting risk assessments of excipients, and assessing and controlling nitrosamine and elemental impurities.
- Managing and evaluating outsourcing activities (calibration, testing).
- Assessing transportation companies and transportation packaging.
- Evaluating and verifying new customers related to distribution activities in the factory.
- Supervising compliance with SOPs and GMP regulations.
2. Development and management of quality management tools (40%)
- Drafting and updating SOPs related to quality management tools.
- Managing and supervising the implementation of quality-related change controls.
- Managing and supervising the implementation of CAPAs.
- Managing, supervising, and evaluating quality risk management activities.
- Managing, coordinating, and supervising the internal audit process.
- Managing and supervising the process of handling customer complaints.
- Managing and supervising product recall processes.
- Implementing pharmacovigilance activities.
- Planning and coordinating management reviews.
Job requirements:
1. Qualifications and Education
- Bachelor's degree in Pharmacy (Preferably from public universities).
- Proficient in English (reading, writing, listening, speaking).
2. Experience and Professional Knowledge
- Minimum 4 years of experience in the relevant field.
- Experience in sterile drug production.
- Preference given to candidates with experience working in EU-GMP certified factories.
3. Skills and Qualities
- Careful, responsible, and proactive.
- Hardworking and diligent.
- Good ethical standards and honesty.
- Teamwork skills.