医薬品 総括製造販売責任者 – 横浜
QP / QUALIFIED PERSON / SOUSEKI (M/F/X) – Yokohama
Become the wind beneath our wings in all pharmaceutical and drug-related issues.
GENERAL INFORMATION
Position: 医薬品 総括製造販売責任者
Location: 横浜
Starting: 要相談
Position: QP / Qualified Person / Souseki (m/f/x)
Location: Yokohama
Starting: at the next possible date
YOUR NEW NEST:
THE FORCE builds companies for companies in the healthcare, pharmaceutical, and medical devices sector.
We encourage work in a flexible surrounding and as a diverse group when it comes to gender, nationality, religion, and ways of working. This unique culture is aimed to integrate employees and partners seamlessly into one organization.
Likewise, this organization shall easily adapt to customer organizations. Our unique way of operation will release THE FORCE to solve customer problems in a fast, effective, and efficient manner.
PEOPLE ARE OUR STRENGTH:
In all of this, people are and will be at the center of our attention, and the most valuable asset we have: People are our strength. They make us THE FORCE.
For you, this means you are flexible in your working hours, your location, and your work itself. You will also have a big say in what exactly you and we are aiming for. But above all, we are interested in you as a person and focus on your specific talents. We are looking for that certain something – and will give it to you in return.
THE FEATHERS IN YOUR CAPS:
- 日本の薬剤師資格をお持ちの方
- 日本国内において、医薬品の品質管理または市販後安全管理に関連する業務に3年以上従事した経験をお持ちの方
- 高い分析力と問題解決能力をお持ちの方
- チームがあなたの助けを必要としているため、自分のポジションに直接関係のない仕事を引き受けることができるチームプレーヤー
- 日本語の読み書きができれば、社内のコミュニケーションも円滑に進みます。英語の基礎知識があればより好ましい。
- You’ve been successfully certified as a pharmacist in Japan.
- You’ve got 3+ years of experience related to quality control or post-marketing safety control of pharmaceutical products, or other similar work in Japan.
- You possess strong analytical thinking and problem-solving skills.
- You don’t get your feathers ruffled when it comes to taking on tasks that aren’t directly related to your position because your team needs your help.
- Your fluency in Japanese allows for a smooth communicate with the team. Basic knowledge of English is a plus.
THE TASKS YOU’LL TACKLE WITH YOUR WISDOM:
- 日本の法規制に基づき、QP（Qualified Person）／総括責任者の責務を果たす
- 第一類医薬品、第二類医薬品、医薬部外品、場合によっては化粧品の製造販売許可を取得または維持するために、社内でGQPおよびGVPを確立する
- 日本のGxP状況、医薬品の製造・管理状況を、常に各ガイドラインに沿ってモニターする
- 細部にまで目を配り、上市前のバッチの市場リリース、継続的なリリース登録の維持、PQRの年次作成を担当
- 向精神薬の責任者の業務を担
- コンプライアンス遵守とバリデーション措置の承認を担当
- 内部および外部監査の実施
- 行政や顧客との窓口となる
- 薬事・薬事法に関するあらゆる問題について、社内外にアドバイスやサポートを行う
- You perform the responsibility of a Qualified Person (QP) / Soukatsu Sekininsha according to Japanese regulation.
- You establish GQP and GVP in-house to be granted or maintain the manufacturing and selling licenses for Class 1 pharmaceuticals, Class 2 pharmaceuticals, quasi-pharmaceutical drugs, and possibly cosmetics.
- You monitor Japanese GxP status as well as manufacturing and testing of medicinal products – always with regard to the respective guidelines.
- With an eye for detail, you take care of market releases of batches before they’re placed on the market, maintenance of the ongoing release register, and annual preparation of PQRs.
- You handle the tasks of the responsible person for narcotics.
- You take care of the approval of qualification and validation measures.
- You carry out internal and external audits with vigilance.
- You act as a contact person for authorities and customers.
- You provide advice and support for colleagues as well as customers in all pharmaceutical and drug law related issues.
NO MATTER IF EARLY BIRD OR NIGHT OWL:
You are flexible in your working hours, your location, and your work itself. You will also have a big say in what exactly you and we are aiming for. But above all, we are interested in you as a person and focus on your specific talents.
We are looking for that certain something – and will give it to you in return. Odd bird, crazy goose, or wise owl? We welcome birds of all feathers!
READY TO SPREAD YOUR WINGS?
Send us your application directly via our application form.
