Hobson Prior are looking for a Quality Operations Consultant to join a world-wide biopharma organisation focused on improving the lives of patients globally through pioneering medicines. This is a contract position based in Switzerland and please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• You will work with Senior Quality manager in providing Quality oversight of routine operations at CMOs in support of cell therapy (CAR T) intermediate product manufacturing.
• 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.
• To work with CMO Quality to ensure a robust batch release process in accordance with agreed processes and defined timelines.
• You will 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.
• May occasionally be responsible for batch record review of intermediate product and system release.

Key Skills:

• Ability to prioritize and successfully manage complex and competing tasks.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Ability to work in a fast-paced environment.
• Able to work self-sufficiently and reliable with regards to quality and timeframes.
• Very good verbal and written communication skills.

Requirements:

• Requires a bachelor's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas or comparable education with experience in GMP industry.
• Fluent in English.
• First experience in EU GMP regulated industry within in quality assurance, quality control, or manufacturing Knowledge of relevant regulations and guidance.
• Experience within the Cellular Therapeutics environment.
• Experience with biological manufacturing and related documentation.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.