【薬剤師】QAシニアマネージャー

英語力をいかしシニアマネージャーとして品質保証業務を担う

仕事内容

The Company Pharmacist is a company registered pharmacist (医薬品製造管理者) and Senior Manager/ Head of Quality for Japan. He or she ensures operational compliance of GMP Ministerial Ordinance and Japan Osaka Pharmaceutical warehouse (Packaging, labeling and Storage) leading the team under GMP organization and handles all Quality related activities for products in alignment with business objective ensuring legal and regulatory compliance.

Key responsibilities ：
Company Pharmacist
・Lead Manufacturing and Warehouse activities Coordinate, manage and ensure manufacturing activities in warehouse is operating in accordance to GMP requirements and revised PMD Act. Review product labels as per regulations.
・Lead Warehouse Sample management for excipients and API products: Prepare and report function, usage and characteristics of samples prior to custom clearance. Ensure samples are handled in accordance to GMP regulation. Manage pre-delivery lot sample validation with external vendors (laboratory) and records as per regulations. Manage reference samples.
・Product Quarantine and Release management Ensure all imported products (including but not limited to APIs) are quarantined and validated prior to distribution before giving release judgement. Ensure clear segregation of products status as per GSP requirement. Coordinate and submit JP test to external laboratories for product testing.
・Product Complaint: Recall and Disposal management Monitoring of deviations and CAPA report. Ensure on time reporting of product recall to Osaka prefecture and follow through product recall procedure. Verification and validation of disposal process and related reports.
・Prepare and support customers’ product registration pertaining to warehouse.
・Support and maintain records of Authority and customers’ audit.
・Attend GMP related training and provide training to warehouse and related employees.
・Records and Documentations: Review and ensure all GMP documents and related records are complying with GMP regulations in Japan.
・To check domestic or overseas QA-related pharma application documents.
・To verify or approve creation or modification of SOPs.

Quality：
・Take the lead on all Quality related activities in Japan.
・Implement and lead the Total Quality deployment, Quality Risk Management and Pharmaceutical Quality Systems.
・Customer request and complaint handling including coordination with overseas manufacturing sites, preparation of investigation reports and take appropriate remediation action plans.
・Manage customer expectations and queries (Questionnaire, Quality statement, Quality Agreement
・Manage and prepare QA related documents (SOPs, COAs, CAPAs, Deviations, Product Quality Review, Quality Agreement, Change Control etc.)
・Monitor stability studies of products where relevant.
・Manage periodical GMP inspection by authority and customers’ audit.
・Participation in GMP committee of Kansai Pharma Association and QA related seminars.

応募条件

【必須事項】

・A minimum of bachelor’s degree in Pharmacy.
・Pharmacist license.
・High level of knowledge and understanding on GMP.
・Practical experience in GMP more than 8 years. (example in Manufacturing, Packaging, labeling and/or Storage) （目安）
・Experience in customer complaint handling.
・Good business level of English communication skills (Oral and Writing).
・Good interpersonal, organizational, team player and problem-solving skill.
・Wide knowledge on Pharmaceutical regulations and QA/GMP standards (ICH guidelines, PICs GMP, IPEC GMP, ISO 9001, FSSC 22000 standards)
・Experience on QC analysis and testing

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

3ヶ月

勤務地

大阪

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスタイム制
コアタイムあり
　09:30 ～ 17:30

勤務開始日

応相談

休日休暇

土日祝
年間有給休暇：　
法定休暇：年次有給休暇、産前産後休暇
特別休暇：夏季休暇、年末年始休暇
その他休暇：慶弔、疾病休暇

年収・給与

年収　　～1200万円　経験により応相談

諸手当

交通費、業務手当、出張手当（海外）

昇給

年1回（1月）

賞与

年2回（6月・12月）、評価賞与年1回（2月）

採用人数

1名　

待遇・福利厚生

通勤手当：有

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
退職金制度：有

選考プロセス

１）書類選考
２）一次面接
３）最終面接