Commercial Release Specialist Parenteral

☞ Biogen

View: 214

Update day: 21-03-2024

Location: Baar Zug ZG

Category: Quality Assurance / Quality Control R & D Science Labor

Industry: Research Services Biotechnology Research Pharmaceutical Manufacturing

Position: Associate

Job type: Full-time

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Job content

Job Description

About This Role

The Commercial Release Specialist Parenteral is responsible for disposition pack preparation for all manufacturing steps and Biologics Drug Substances (DS) or Active Pharmaceutical Ingredients (API) technical release as per Swiss Regulation and European Directive as well as delegated regulation.

What You’ll Do
  • Ensure appropriate training and organization to perform release on time
  • Follow up with CMO’s Quality with regards to the batch documentation or missing information.
  • Review and verification of batch release documentation according to local procedures and product specific checklist
  • Collect & Perform Key Process Indicators analyses including feedback from other departments (for example planning). Identify appropriate actions and ensure successful implementation
  • Manage Stakeholder as release specialist for release activities
  • Support local Quality system (change control, deviations, CAPAs, APRs, CMO assessment …) as required
  • Identify and drive improvements/updates of the GMP documentation related to release activities
  • Identify and communicate timely to the management any supply risk or risk of batch rejection for API/DS/DP
  • Participate matrix teams within a product program cross functionally or at global level.
  • Identify possibility for improvement/standardization in the purpose of continuous improvement of the system used
Who You Are

You can adapt quickly to several changes, shift priorities and possess strong negotiation skills.

The ideal candidate likes to coordinate with Quality colleagues and cross-functional departments (i.e. External Manufacuring, Logistics and Planning) on batch status, on Certificate of Analysis status, Annual Product Review, CMO assessments, Deviations, changes and CAPAs related to the batch documentation and approved as needed.

Qualifications

Required Skills
  • A minimum of 1 year of experience in similar position in pharmaceutical or biotechnology industries
  • Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling). Sound knowledge of cGMP requirements, EU/FDA regulations and compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.
  • Strong communication skills.
  • Ability to work in an international matrix environment.
  • Solid negotiation skills
  • Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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Deadline: 05-05-2024

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