Salary: Wage agreement (Based on candidate's experience and ability)
Job decriptions:
- Coordinate with manufacturers and prepare dossiers for medicine and non-medicine (Medical device, cosmetic, and food supplement) product registration (Renewal registration, variation registration, new registration) or product import quota and submission to Regulatory authorities (DAV).
- Monitor the registration status of products in DAV and other regulatory agencies.
- Follow to get the approval of marketing authorization, import quota, variations in timely manner.
- Support Business team in applying for advertisement licenses & detail aid material printing permits.
- Coordinate with Business team to support for product’s availability on market.
- Supply the required information/documents for requirements of external or internal colleagues including Health Authorities (Ministry of Health) to conform to Company’s regulations and law.
- Develop artwork required for packaging to secure new product launching and secure stock for sales.
- Supervise and support daily workflow of Regulatory Affairs staff.
- Promotional material registration:
+ Review promotional material, and support Marketing to revise in accordance with DAV’s requirements.
+ Submit dossier in time and follow up on the submission process.
+ Review product information published on MIMS/VIDAL.
- Other duties: Hospital tender supports: provide documents (GMP, CoA, CPP...), official letter (explanation/commitment,.) to support hospital tender application.
- Other tasks are assigned by Regulatory Affairs Manager.
- Prepare reports required by Regulatory Affairs Manager.
Job requirements:
- Medical/ Pharmaceutical University graduated.
- At least 3-year experience at the same position.
- Good English skills.
- Good MS office skills (Word, Excel, PowerPoint, Corel/AI).
- Understanding of regulatory rules and regulations of the Ministry of Health.
- Good communication & office administrative skills.
Detailed information about the job will be discussed directly in the interview.
Salary: Wage agreement (Based on candidate's experience and ability)
Job decriptions:
1. Document Management (Paper & Electronic) (60%)
- Prepare SOPs assigned by the direct supervisor.
- Compile and update the Site Master File.
- Manage the distribution, retrieval, destruction, and storage of documents according to regulations.
2. Training Management and Coordination related to GMP (30%)
- Update the training matrix according to regulations.
- Plan and monitor factory training.
- Coordinate internal/external training activities.
- Ensure training activities are implemented according to SOPs.
3. Quality System Monitoring (10%)
- Manage quality measurement indicators (Quality KPIs).
- Coordinate the implementation and reporting of periodic or ad-hoc quality management system reviews by management.
4. Perform other assigned tasks (if any)
- Coordinator in consulting work.
- Other tasks.
Job requirements:
1. Education and Degree:
- Bachelor's degree in Pharmacy
- English proficiency (reading, writing, listening, speaking)
2. Experience and Expertise:
- Minimum of 2 years of experience in a relevant field
- Prioritize candidates with experience working in an EU-GMP factory
Salary: Wage agreement (Based on candidate's experience and ability)
Job decriptions:
1. Product Research and Development Role (30%)
- Conduct characterization studies of raw materials and excipients;
- Conduct formulation and process research in the laboratory;
- Prepare registration dossiers for content related to formulation and process;
- Evaluate the stability of research products.
2. Role in Production Equipment Validation (40%)
- Prepare URS for production equipment to meet planned production processes;
- Participate in risk assessment, DQ, FAT/SAT, IQ, OQ of production equipment.
3. Technology Transfer Role (20%)
- Participate in the transfer and validation of production processes at the factory or with external partners;
- Prepare master formulas, production processes, outlines, and reports for process validation.
4. Other Tasks (10%)
- Perform other tasks as assigned by the RD Manager.
Job requirements:
1. Education and qualifications:
- Minimum: Bachelor's degree in Pharmacy.
2. Experience and expertise:
- Minimum 03 years of experience working in QA, RD or Production departments in a sterile pharmaceutical manufacturing plant;
- Priority for candidates with experience in validation or operation of production equipment in an injection manufacturing plant.
3. Abilities and qualities:
- English: minimum reading comprehension of specialized documents;
- Careful and meticulous work personality;
- Ability to self-study and update knowledge and regulations related to the scope of work;
- Ability to work independently, ability to analyze problems and manage work well within the scope of work.
Salary: Wage agreement (Based on candidate's experience and ability)
Job decriptions:
1. Internal Communications (75%)
1.1. Implement engagement programs:
- Collaborate with T&D specialists to plan and organize internal and partner engagement events (at least 1 activity per quarter).
- Select and implement appropriate internal communication channels/activities for each program: Orioled Hub bulletin board, MS Team channels, company postcards, internal email marketing, etc.
- Record metrics and create reports to evaluate the effectiveness of communication activities.
- Collaborate with club leaders to communicate club activities.
- Collaborate with the EB department to communicate internal activities to the outside.
1.2. Manage internal communication channels:
- Distribute, update, manage and develop internal communication information for the entire company.
- Maintain interaction and discussion on internal communication channels.
- Answer questions (if any).
1.3. Coordinate internal communication content production:
- Coordinate the production of internal communication content and materials for the company.
- Collaborate with the EB department to produce video publications, postcards, etc. to support internal communication maintenance and development.
2. Company Branding Publications (20%)
- Collaborate on ideas for company branding publications (notebooks, calendars, pens, bags, etc.)
- Design publications (in collaboration with the company's supplier or designer)
- Find suppliers to produce publications.
- Monitor costs and production processes until the final product is completed.
3. Other tasks (5%)
- Support logistics for training programs
- Perform other work related to the job when required.
Job requirements:
1. Education and qualifications:
- Minimum: College degree or higher in Communications, Marketing or related fields.
- Languages: English reading and writing.
- Internal communication tool skills: Proficiency in using tools such as internet, postcards, email marketing software, etc.
- Basic Canva design skills
2. Experience and expertise:
- Experience in internal communications at small and medium-sized companies.
- Mindset for corporate culture development and internal communications development
- Experience in working and negotiating with suppliers (production of branding publications, event organizing agencies, etc.)
- Regularly update internal engagement content and trends.
- Priority: candidates born in 2K or later (young and dynamic)
3. Abilities and qualities:
- Sociable
- Good problem-solving.
- Good Communication.
- Responsibility and initiative.
- High ability to keep confidential information
- Hardworking, diligent.
- Good writing skills is a plus.
- Careful, meticulous, attention to detail.
- Energetic and perceptive.
- Willing to learn and not afraid to try new things.
- Adaptable to a flexible working environment.
- Have the ability to organize and manage work according to plan.
The recruitment information will be updated regularly on the website https://tvtpi.com.vn/ and other recruitment pages. Leave your application information here: https://forms.gle/ghqJK45D2Pc5GWEK9
For any questions about the vacancy and application, please contact the HR department during office hours by phone: 0969 813 694 or email: orioledportal@orioled.com.sg
