QA Expert - Clinical Supplies and Packaging
Prismond Group SA
Zurich, Switzerland
vor 5 Tg.

Role & Responsibilities

Review of batch documents for label release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements

GMP review of batch documents and disposition of Clinical Batches for use in clinical trials

Deviation and change handling for packaging, lab investigations and related records

Act as contact person for complaints and temperature excursions

Ensure quality and compliance of all qualifications documents

On behalf of Manager Quality Systems, review and approval of specifications for clinical use and of method validation summaries

Preparation and implementation of procedures related core tasks

Responsible for metrics related equipment qualification

Issue reports summarizing deficiencies and work with areas to execute remedial action

Communicate and resolve audit comments with client areas

Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards

Review and approval of SOPs

Position Requirements

University degree in Quality, Engineering, Sciences or another relevant discipline

At least 1-3 years of experience within a GMP-regulated environment, preferably in the Pharmaceutical or Medical Devices industry

Broad working knowledge of cGMP regulations; basic understanding of manufacturing process

Analytical and structured working style; strong attention to detail

Ability to effectively work as part of a multidisciplinary, international team

Good verbal and written communication skills in English, German language is a plus

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