QA operations - Biotech (1 year assignment)

Job content

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!