【今市】医薬品規格・試験法の文書作成スタッフ

Job description

職務の目的および主な業務内容 医薬品製造に使用される原薬・副原料・製品等の品質規格ならびに試験法の文書化 分析機器のバリデーション 分析機器のアクセス管理/データのバックアップ・リストア/監査証跡レビュー ※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 医薬品の分析スキルあるいは規格及び試験法の文書作成スキル 組織内のあらゆるレベルで良好な業務関係を築く能力 締め切りを守るための作業計画、整理、管理能力 文章および口頭でのコミュニケーション能力 経験 医薬品GMPにおける活動経験 学位/資格/語学力 学士号またはそれに値する知識/経験 望ましい条件 スキル 分析機器のバリデーション実施経験 経験 チームを率いて業務を遂行した経験 学位/資格/語学力 英語を用いたコミュニケーション Skills Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Problem Solving, Project Management, Quality Assurance (QA), Risk Awareness, Technical Writing, Validation Processes Why 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 APACRecruitment.Adjustments@gsk.com. 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.