Reasons could include the position has been filled or the company is not accepting new applicants.
Job Description
Job Summary:
To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements.
Maintain the FCS Japan Quality System in compliance with the specified procedures, policies and requirements.
Liaise with clients, customers on quality related matters.
Duties and Responsibility:
Education/Qualification:
Bachelor’s degree in life science or related medical/Pharmacy/Quality Assurance & Regulatory affair or higher
Experiences:
1. Strong QA and Production experience for 5 years+
Or
2. GMP/QMS settings in the field of quality assurance and regulatory affairs for 5 years+
Ability/Skills:
3. Knowledge of IMP process, preferably to include handling complex protocols, key clients and business objectives
4. Ability to handle complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
5. Flexible and adaptable with strong customer management skills.
6. Ability to work independently under pressure and prioritize multiple tasks
7. Ability to lead and influence, and to support others within team
8. Good organizational skills
9. Good written and verbal communication skills in Japanese and English