Job opening - QA GQP Senior Specialist：外資系製薬企業 in 東京23区 | Randstad

summary

東京23区, 東京都
¥10,000,000 - ¥13,000,000 per year, 年収1,000 ～ 1,300万円
permanent

job category
biotechnology & pharmaceutical

job details

社名
社名非公開

職種
安全性管理、品質保証、品質管理

業務内容 ...

Ensure GQP compliance and contribute to the stable supply of pharmaceutical products in a dynamic and collaborative environment.■About the companyOur client is a global leader in the pharmaceutical industry, renowned for its commitment to quality and patient care. They offer a collaborative and supportive work environment with opportunities for professional growth.■Role & ResponsibilitiesYou will be a key member of the Quality Assurance team, managing GQP activities for the Marketing Authorization Holder. You will work closely with manufacturing sites, ensuring robust quality systems are in place and compliance with all applicable regulations. You'll lead investigations, support regulatory filings and inspections, and collaborate with cross-functional teams to maintain a compliant and stable supply of high-quality products. This is an excellent opportunity to utilize your expertise in a challenging and rewarding role, contributing to the advancement of healthcare.■Main tasks include・Manage manufacturing site deviations, significant investigations, and change controls.・Support change control activities for regulatory filings and product launches.・Support GMP audits and remediation of audit gaps.・Conduct quality due diligence assessments for new external partners.・Support compliance activities related to Japan Pharmacopeia and regulatory requirements.・Collaborate with various departments (e.g., Regulatory Affairs, Pharmacovigilance) to ensure GQP compliance.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid

求められる経験
■Requirements
・Bachelor's degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or a related field.
・Extensive experience in Quality Assurance within the pharmaceutical industry.
・Strong knowledge of GMP, regulatory standards, and pharmacopeial standards.
・Demonstrated experience in managing deviations, investigations, and change controls.
・Business-level proficiency in Japanese and English.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,000 ～ 1,300万円

賞与
給与に賞与14%と裁量労働手当込み
雇用期間
期間の定めなし

show more

社名
社名非公開

職種
安全性管理、品質保証、品質管理

業務内容
Ensure GQP compliance and contribute to the stable supply of pharmaceutical products in a dynamic and collaborative environment.■About the companyOur client is a global leader in the pharmaceutical industry, renowned for its commitment to quality and patient care. They offer a collaborative and supportive work environment with opportunities for professional growth.■Role & ResponsibilitiesYou will be a key member of the Quality Assurance team, managing GQP activities for the Marketing Authorization Holder. You will work closely with manufacturing sites, ensuring robust quality systems are in place and compliance with all applicable regulations. You'll lead investigations, support regulatory filings and inspections, and collaborate with cross-functional teams to maintain a compliant and stable supply of high-quality products. This is an excellent opportunity to utilize your expertise in a challenging and rewarding role, contributing to the advancement of healthcare.■Main tasks include・Manage manufacturing site deviations, significant investigations, and change controls.・Support change control activities for regulatory filings and product launches.・Support GMP audits and remediation of audit gaps.・Conduct quality due diligence assessments for new external partners.・Support compliance activities related to Japan Pharmacopeia and regulatory requirements.・Collaborate with various departments (e.g., Regulatory Affairs, Pharmacovigilance) to ensure GQP compliance.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid ...

求められる経験
■Requirements
・Bachelor's degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or a related field.
・Extensive experience in Quality Assurance within the pharmaceutical industry.
・Strong knowledge of GMP, regulatory standards, and pharmacopeial standards.
・Demonstrated experience in managing deviations, investigations, and change controls.
・Business-level proficiency in Japanese and English.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,000 ～ 1,300万円

賞与
給与に賞与14%と裁量労働手当込み
雇用期間
期間の定めなし

show more

experience
■Requirements ・Bachelor's degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering

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