Job Description
We are seeking a Batch Release Manager to strengthen our quality assurance team.
Salary
The position is full-time, with the possibility of partial home office depending on the role.
Key Responsibilities
* Classification and final assessment of deviations, including coordination of activities in processing deviations, ensuring timely completion of investigations.
* Approving critical GMP documents.
* Supporting root cause analysis and definition of meaningful CAPAs.
* Deputy Qualified Person (QP) and Deputy fachtechnisch verantwortliche Person (FvP), playing a key role in ensuring product quality.
* BATCH RELEASE AS DEPUTY QUALIFIED PERSON/FACHTECHNISCH VERANTWORTLICHE PERSON FVP.
* Ensuring compliance with relevant cGMP®ulatory requirements.
* Providing clear updates on release status, risks, and issues to stakeholders.
* Proactively identifying capability gaps and defining the path to building new capabilities within Quality.
* Collecting, monitoring, and reporting Key Performance Indicators (KPIs).
* Support during Health Authority Inspections and Customer Audits.
* Performing Supplier Audits.
* Supporting creation and review of annual Product Quality Reviews & Management Reviews.
Required Skills and Qualifications
* PhD or MSc in Pharmacy, Biology, Microbiology, or Chemistry.
* 5+ years of experience in GMP-regulated environments.
* Profund knowledge of Swiss, EU, and US Good Manufacturing Practice Regulations.