Rare opportunity to step up as the head of R&D and cooperate with the commercial side as well. You will have direct management responsibility and will lead the QA function in support of all Japan commercial operations.
* Manage the roles of Quality Control, Quality Assurance and Safety Control in Japan
* Support to achieve Japan Commercial Operations objectives from Quality Assurance perspective
* Maintain and continually improve the quality processes and procedures in Japan commercial operations
* Meet regulatory requirements a ...
* Export Trade Control classification/H S code/Chemical regulatory screening and prepare and submit the related applications and documents for chemicals, reagents, equipment, apparatus and machinery, and industrial products that the company import, export, purchase, manufacture, and sell.
* Export Trade Control classification /H S code/Chemical regulatory screening and prepare and submit the related applications and documents for chemicals, reagents, equipment, apparatus and machinery, and industrial products that the company import, ...
Safety information and measures for over-the-counter drugs. Supporting periodic safety reports side effects and implementation of risk management plan.
- Planning of safety measures for over-the-counter drugs (providing information to healthcare professionals and patients, etc.)
- Immediately after marketing survey-related work
- Contract, self-inspection, education, procedure manual related work
GPSP-related work (management of post-marketing surveillance, planning, response, PMS progress management, etc.)
・ Production technology (film / sheet, extrusion molding, injection molding, vacuum forming, inflation, etc.)
・ Development of mass production process
・ Optimization of manufacturing process (improvement of yield, reliability, maximization of production efficiency)
・ Line safety measures
・ Negotiations and work guidance with partner companies that outsource production
・ Pursuing the cause and implementing countermeasures when a defective product occurs
* Engaged in overseas business on a business trip basis.
For the purpose of improving the quality of our own products, we would like quality control, complaint handling, outsourcer management, etc.
・ Management work
・ In-house quality standard setting, quality standard confirmation
・ Confirmation of plan quality compatibility during product development
・ Outsourcing audit and manufacturing witness
・ Quality complaint and trouble response
・ Maintenance of cosmetics manufacturing and sales industry ...
【Overall Purpose Of The Job】
• The Near Patient Quality Assurance Lead (NPQAL) is responsible, on behalf of the Head of Clinical Quality for driving patient quality through continuous improvement in service experience design, implementation and analysis in the near patient teams.
• The NPQAL will develop relationships with the Military Treatment Facilities, beneficiaries and purchased care provider offices in order to support the quality assurance function.
• They will design and follow initiatives to enhance customer experience through mon ...
1. Responsible for the day to day operations in the laboratory including clinical blood sample handling utilizing automated liquid handlers, operating Lab equipment, and troubleshooting technical issues.
2. Lead the quality assurance of our laboratory.
3. Work in collaboration with Laboratory manager and Global Head office ...
For two to five years, you will learn the work of the production section (manufacturing department) at the Kanbara factory in Shizuoka prefecture, and then you will be assigned to the Kentucky factory.
① People who are interested in manufacturing (Production Manager candidates)
② Those who are willing to live in Kentucky
R & D / Organic / Polymer, Materials Engineering, Chemical Engineering, Inorganic / Metal
Development of industrial rubber parts, compounding design and evaluation of rubber materials, product process desi ...
[Tokyo] Pharmaceutical Affairs / Quality Assurance Manager-Medical device / medical care product manufacturer accelerating global expansion-
At our company, which manufactures and develops various medical products in the orthopedic field and pressure ulcer / wound field, you will be in charge of pharmaceutical affairs and quality assurance work.
In order to achieve our medium-term business strategy, we are strengthening our expansion into overseas markets in addition to our main domestic business, and the overseas sales ratio is currently around 4-5%, ...
Job details <Pharmaceutical application>
・ Acceptance and confirmation of application
・ Regulation survey, negotiations with related ministries and agencies
・ Negotiation with sales
・ Preparation of application documents
・ Application practice ...
① CMC research position (quality assurance of investigational drug GMP) *Supervisor/manager*
1. Quality assurance and reliability assurance of investigational drug GMP, PIC/S, data and materials in accordance with internal regulations
2. Inspecting regulatory authorities and affiliated facilities (Tokushima, Saitama)
3.Outsource contractors/partners, Vendor audits of raw materials and additives, and continuous guidance (raw materials, drug products)
4. Management and transmission of quality-related documents
① "Candidate position":
A future “leader candidate” who will be in charge of quality evaluation and clinical trial research of drug substance manufacturing as a contact point for development themes that are new drug candidates
② "Management candidate":
"Candidates for managerial positions" who are in charge of instructing the development and development of standards and test methods for clinical trial drug substances according to the development stage toward the application for approval of new drugs ...
1. Regulatory investigation work in each country
2. Coordinate with overseas sales companies and our subsidiaries to formulate pharmaceutical affairs strategies, application for approval and maintenance after sales
Business to lead internal departments together according to the Pharmaceutical Affairs Strategy formulated in 3.2 ...