職務の目的および主な業務内容
職務目的
薬機法およびGMP省令を遵守し、「主な業務内容」に記載された関連手順書に従って業務を遂行する。加須製造業品質部門の一員として、品質保証上の役割と責任を果たすとともに、製品出荷を遅滞なく確実に実施する。
また、将来的には製造管理者の職務を担う可能性を踏まえ、製造業全体の業務および品質管理体制を体系的に理解し、適切な管理が行える人財となることを目指す。そのため、広い視野と責任意識を持って業務に取り組み、継続的な成長と組織への貢献を図る。
主な業務内容
加須製造業の一員（将来的には製造管理者も視野に）として：
- 加須製造業の品質部門及び製造部門と連携・協働をし、業務を遂行する
- 関連部署と合意したスケジュール通りに、GMP及びGQP出荷判定を行う
- 出荷判定に加え、加須製造業における試験検査、文書及び記録管理、バリデーション、定期的製品照査、変更管理、逸脱処理、品質情報処理、回収処理、自己点検、外部委託業者管理、教育訓練、薬事対応などを遂行する
- 当局査察の際は、事前準備、当日の対応及び指摘事項に対するアクションを遂行し、加須製造業の業許可を維持する
- 逸脱や製品不良などが生じた際は、海外製造所と社内関連部署、製品によっては他社製造販売業者にも報告を適切に行い、品質と法令遵守を考慮した最適解を立案し、関係者へ説明をする
- GSK QMS（Quality Management System）が新設や改訂された際、加須製造業への影響評価を行う
※職務内容および勤務地の変更範囲は会社の定めるところとする。
必要な条件
スキル
- 自部門や関連部署と適切に連携しながら業務を推進するためのコミュニケーション力やリーダーシップ力、及び、課題解決に向けて選択肢を提示できる問題解決力を有すること。
- 薬機法やGMP省令に関する理解を有すること。
経験
- 品質関連業務の経験や知識
学位/資格/語学力
- 薬剤師免許の所持
- 英語：メールやCallにて、海外の製造サイト等とコミュニケーションが取れる程度の英語力
望ましい条件
スキル
- AIツールの活用等、新たなアプローチを適切にリスク評価した上で導入し、継続的な業務改善を推進できるマインドを有すること。
経験
- GMP、GDPまたはGQP関連業務の経験
- 当局査察の対応経験
*就業場所： 東日本物流センター 埼玉県加須市北大桑152-1
*リモートワーク：不可
Skills
Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical WritingWhy GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Skills Required
- Pharmacist license
- Understanding of Pharmaceutical and Medical Device Act (薬機法) and GMP ordinances (GMP省令)
- Experience in quality-related operations (testing, document/record management, validation, change control, deviation handling, recalls, supplier management)
- Ability to perform GMP and GQP product release decisions per agreed schedules
- Strong communication, leadership and problem-solving skills to coordinate cross-functional stakeholders
- English ability sufficient for email and calls with overseas manufacturing sites
- Experience with GMP, GDP or GQP-related operations
- Experience responding to regulatory inspections
- Familiarity with using AI tools or digital approaches for process improvement
GSK Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GSK and has not been reviewed or approved by GSK.
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Strong & Reliable Incentives — Compensation is characterized as including strong salary and perks, with annual bonuses and long-term incentives contributing materially to total rewards. Recognition and performance-linked rewards are described as a consistent component of the package.
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Healthcare Strength — Health coverage is presented as comprehensive, spanning medical, dental, vision, disability, life insurance, and mental health benefits. The breadth of coverage is repeatedly framed as a standout element of the overall rewards experience.
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Retirement Support — Retirement offerings are described as robust, anchored by a 401(k) plan and additional savings vehicles such as employee stock purchase programs. Employer contributions and savings options are portrayed as meaningful supports for long-term financial security.
GSK Insights
What We Do
A science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.
