募集要項
- 募集背景
- A market leader in the biochemical and healthcare industries is looking for a Regulatory Affairs Associate. The selected candidate will lead the validation program, internal audit and key training for internal employees.
- 仕事内容
-
A market leader in the biochemical and healthcare industries is looking for a Regulatory Affairs Associate.Responsibilities:
* Manage relevant documents such as SOPs, Validations, Quality Agreement, Licences, etc.
* Oversee the document management system
* Ensure sufficient maintenance of aster File, BSE Cert, ISO Cert, Halal Cert, Kosher Cert, HACCP Cert
* Facilitate GMP / ISO training for company's staff
* Assist in hosting GMP inspections, certified body audits, customer and corporate audits
* Handle customers and authority requests to boost customer satisfaction
* Enhance regulatory compliance with global and local regulations, standards such as GMP / QMS, IPEC and ISO
* Resolve personnel issues and workplace conflicts
Requirements:
* Bachelor's degree or higher, preferably in pharmacy, chemistry, biology, or equivalent
* Work experience in regulatory affairs or quality assurance within the pharma or food industry
* Expertise in GMP / QMS, IPEC, ISO, other regulations / standards
* Knowledge of qualifications and validations
* Understanding of data integrity
* Outstanding MS Office skills
* Collaboration and leadership skills
* Native Japanese; business level English
- 応募資格
-
- 必須
- Work experience in regulatory affairs or quality assurance within the pharma or food industry
- 歓迎
-
英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Kanagawa
- 年収・給与
- JPY6,000,000.00 - JPY9,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇