大手外資製薬企業におけるAdvanced QA Professional

募集要項

仕事内容

・Projects move fast, and quality has to keep pace. You will be part of project and validation work from the start, helping teams solve quality issues and deliver with confidence.
・Provide QA oversight of projects at the Koriyama Factory, helping them deliver on time and at the right quality.
・Take part in project and validation activities, solving quality-related issues together with project teams.
・Perform quality spot checks during validation projects, and review and approve validation documents, complex change control requests and SOPs.
・Make sure quality-related decisions reflect current Novo Nordisk procedures and health authority requirements, and that both you and the site stay compliant.
・Take part in audits and inspections, and coach colleagues through them.
・Give departments proactive quality guidance and facilitate validation and other internal training when needed.

応募条件

【必須事項】

You care about quality and you’re confident making clear, well-reasoned decisions in a GMP environment. To succeed in this role, you will bring:

・Fluent English, spoken and written
・Japanese at JLPT N2 level or above, so you can work comfortably with colleagues across the site.
A strong quality mindset and an understanding of what manufacturing regulatory compliance means in daily manufacturing work.
The ability to work accurately and to deadline, both independently and as part of a team, while prioritising a changing workload.
Strong relationship-building skills and the ability to explain detailed quality information clearly to colleagues in other functions.
A proactive, adaptable approach and the willingness to mentor colleagues and recognise their contributions.

【歓迎経験】

・A scientific education, for example as a pharmacist, engineer, biologist or equivalent.
・Around 5 years of experience in production, QC and/or QA, ideally in the pharmaceutical industry.
・Strong knowledge of cGMP production processes, quality management systems and validation in pharmaceutical manufacturing.

【免許・資格】

特になし

【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

福島

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
フルフレックス（コアタイムなし）

勤務開始日

応相談

休日休暇

年間休日数：122
土日祝
年間有給休暇：入社半年経過時点10日　10日 ～ 20日
法定休暇：年次有給休暇、産前産後休暇、介護休暇
その他休暇：ボランティア休暇、リフレッシュ休暇など

年収・給与

年収　　700万円～1100万円　経験により応相談

諸手当

通勤手当（全額支給）、時間外手当、住宅手当、その他各種手当有
MRの場合上記に加え、営業手当、外勤日当を支給

昇給

年1回

賞与

年2回

採用人数

若干名

待遇・福利厚生

通勤手当：有
確定拠出年金制度

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接