QA & Commercial Readiness Consultant
- Brussels
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
Contract opportunity to support a rapidly growing Biotech company in expanding their Belgian facility and helping them with Commercial Readiness.
Initially, your responsibilities will include:
- Ensure the facilitation of the preparation for the site readiness to host Belgium Health Authorities.
- Assess the state of readiness versus latest previous observations and remediations stated
- Ensure and drive the completion of open Corrective and Preventive Actions related to inspection readiness
- Define and Coach the Team hosting the inspection for good behaviour and efficiency
- Report to the Site Quality Assurance Manager of progress and difficulties
- Ensure back room support to prepare answers to inspectors during the inspection
- Support the transition of the Site’s Quality Compliance Elevation
- Coach the different subject matters Experts on Quality requirements for commercial readiness
- Coach and drive the actors for the improvement of Deviation, CAPA and Change Control processes
- Ensure the improvements of the Deviation, CAPA and Change Control processes according to Catalent KPI and targets
- Report to the Site Quality Director of progress and difficulties
Profile and background Expected :
- Expert in quality management, Management of teams, mentoring and Coaching of people. (10 years min)
- Capable of interacting with and providing support to departments interfacing with QA, such as QC, Production, R&.
- Former QA Director or Manager, QP could be a plus
- Experiences in QC and QA
- Knowledge in aseptic environment, cell therapies, and Clinical processes.
- Experience in Change and continuous improvement management
The candidate must have the rights to work in the location stated in the job advert.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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