QA operations - Biotech (1 year assignment)
Ver: 158
Dia de atualização: 26-03-2024
Localização: Yverdon-les-Bains Vaud VD
Categoria: Produção / Operação
Indústria: Biotechnology Research Pharmaceutical Manufacturing
Posição: Associate
Tipo de empregos: Contract
Conteúdo do emprego
For one of our clients, a fast-growing biotech industry, we are looking for a QA Operations Specialistfor a 1-year assignment.
The role will be responsible for the Quality oversight of the manufacturing operations of monoclonal antibodies produced at the new large-scale biological manufacturing facility at Yverdon-les-Bains, Switzerland.
The role will cover Upstream and Downstream manufacturing and solutions preparation.
He/she will ensure strong collaboration with other Bioplant functions and will promote compliance and continuous improvement while supporting the on-time supply of products.
Please note that we will only consider candidates living in Switzerland or France.
Duties and responsibilities
• Manage the day-to-day quality oversight of the USP and DSP manufacturing and solutions preparation
• Review manufacturing SOPs to ensure compliance with Incyte Policies and regulatory requirements
• Ensure compliance of manufacturing activities with cGMPs and approved procedures
• Perform Batch Record Reviews within defined timelines
• Manage & Approve deviations, investigations and CAPA plans
• Review, assess and approve the implementation of changes
• Represent QA function in manufacturing routine operational meetings
• Foster compliant and right first-time operations Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
• Operate in close proximity with manufacturing in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events
• Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensure implementation as applicable,
• Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements
Requirements
• Being available to start quickly!
• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
• First-hand experience in Quality Operations for pharmaceuticals at manufacturing sites;
• Thorough knowledge in cGMP and international regulatory requirements;
• Expertise in Biotechnology products
• Strong analytical and problem-solving skills;
• Good verbal and written communication skills with well-structured communication;
• Fluent in French written and spoken (the company language) and ideally good level in English
Have we picked your interest? Please apply online directly!
Data limite: 10-05-2024
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