QA Engineer

Proclinical has partnered with a large biotech in Switzerland, in search for a talented QA Engineer. In this role you will be expected to provide quality oversight at CMOs to support our products.

Job Responsibilities

• Work with Senior Quality manager in providing Quality oversight of routine operations at CMOs in support of cell therapy (CAR T) intermediate product manufacturing May occasionally be responsible for batch record review of intermediate product (Make 1) and system release
• Closing and remediation of detected gaps in collaboration with CMO
• Develop and track KPIs for internal and external performance in relation to batch release activities
• Partner with CMO Quality to ensure a robust batch release process in accordance with agreed processes and defined timelines
• Oversee batch disposition status for European patients and ensuring availability and completeness of documentation required for final drug product release (QP release)
• Review and follow up of CMO deviation investigations, CAPA. Independent review of controlled documents (Master records, protocols, reports, SOPs)
• Support in review and approval of internal investigations and CAPA affecting the CMO
• Partner with stakeholders across different operational functions and participate in projects in order to improve processes
• Support and act in quality related improvement projects in collaboration with affected CMO functions

Skills and Requirements

• Bachelor's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas or comparable education with experience in GMP industry.
• First experience in EU GMP regulated industry within in quality assurance, quality control, or manufacturing
• Knowledge of relevant regulations and guidance.
• Able to work independently and reliable with regards to quality and timeframes
• Very good verbal and written communication skills.
• Ability to work in cross functional teams
• Fluent in English

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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