To strengthen our team in Romandie, we are looking for a quality assurance engineer specialized in pharmaceutical industry.
As a Consultant you will carry out activities to sustain GDP compliance of our client operations.
Your responsibilities :
Ensure that departmental objectives are implemented in line with the overall Quality / Corporate goals.
Act as a champion for departmental understanding and compliance with the requirements of cGMP.
Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
Participate in the batch assessment process to facilitate the timely release of products.
Ensure effective coordination and QA leadership for the CAPA Team, including initiating investigations, root cause analysis, risk assessments and implementation of change controls and Corrective and Preventive Actions as appropriate;
focus on Continuous Improvement opportunities.
Review and proactively assist in process capability studies and statistical techniques as necessary, to support continuous improvement.
Initiate updates / tracking on status of Quality Events and CAPAs as appropriate.
In conjunction with Quality team, evaluate Quality Events / Non Conformances. Identify corrective and preventive action;
determine assignable root cause, complete failure investigations and follow up to corrective and preventive actions, ensuring adequate and timely closure.
QA responsibility for Change Control Requests and Conduct review of Change Control Requests, ensuring compliance with cGMP and quality standard requirements.
Implement Key Performance Indicators for the quality system processes.
Participate in the development and maintenance of the Company's Quality System to meet the requirements of the relevant regulatory authorities.
Your Profile : Academic Level :
Academic Level :
Master, PhD in Quality Engineering with emphasis on pharmaceutical engineering or equivalent with minimum 3 years of experience in Quality Assurance.
Significant experience in a drug manufacturing or biologics industry in Quality Assurance, Quality Control or Quality Engineering position.
Experience of working in a cGMP environment.
Solid experience with internal and external audit processes.
Demonstrated knowledge of cGMPs, MHRA, FDA regulations and SOPs.
Languages : French English. German is a plus.
Key qualities :
You know how to take initiative
You like to work in a multidisciplinary team
You value knowledge-sharing
You must have strong verbal and writing communication capabilities.
Ready to join?
We offer an exciting tailored career path for your professional and personal development within an international company.
You will be accompanied from the beginning with specific coaching and mentoring programs and intensive training on innovation and management in a fast-moving and results driven environment.
We are looking forward to meeting you very soon at Altran!