仕事概要
職種 | 技術職(販売、設計、開発、生産管理)/生産管理、品質管理、施工管理、EHS、PMS |
---|---|
業種 | 医療/ その他医療 |
雇用形態 | 未分類 |
ポジションレベル | その他 |
募集人数 | 1名 |
希望入社時期 | - |
必須語学力 |
英語 (日常会話レベル) 日本語 (流暢に話せるレベル) |
活かせる語学 | - |
勤務時間 | その他 |
福利厚生・休暇 | |
ビザ取得支援 | - |
外国人従業員 | - |
仕事詳細
Company Overview
Global Pharmaceutical company
Job Description
・ Performs a wide variety of activities to ensure compliance with Good Quality Practices (GQP) and Good
Manufacturing Practices (GMP) and Good Distribution Practices(GDP).
・ Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
・ Maintains routine programs and processes to ensure high quality products and compliance with current
GQP/GMP/GDP
・ Reviews manufacturing, environmental monitoring and quality control data for in-process and finished
products.
・ Works directly with operating entities to ensure that inspections, statistical process control analyses and
audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
・ May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA)
recommendations related to manufactured products.
・ Normally receives very little instruction on routine work, general instructions on new assignments.
Requirements
・Demonstrates working knowledge of quality assurance systems, methods and procedures.
・Demonstrates thorough knowledge of GQP/GMP/GDP, and the interface with other functions like manufacturing, distribution and maintenance.
・Demonstrates audit and investigation skills, and report writing skills.
・Demonstrates strong verbal, technical writing and interpersonal skills.
・Demonstrates proficiency in Microsoft Office applications.
・Excellent Japanese and English general communication skills
・Knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations is preferred.
Additional Job Information
・Performs a wide variety of activities to ensure compliance with Good Quality Practices (GQP) and Good Manufacturing Practices (GMP) and Good Distribution Practices(GDP).
・Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
・Maintains routine programs and processes to ensure high quality products and compliance with current GQP/GMP/GDP
・Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
・Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
・May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
・Normally receives very little instruction on routine work, general instructions on new assignments.
面接について
連絡先
QA Specialist
RGFタレントソリューションズ株式会社
600 〜 900 万円