Cleaning Validation SME
- Belgium, Brussels
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
We are looking for an experienced Cleaning Validation SME for a fantastic 3-6 months contract based in Brussels.
You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.
This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.
Responsibilities:
- Ensure the validation of cleaning processes for equipment involved in manufacturing processes (bioprocess) in compliance with GMP and HSE regulations and in accordance with the Site's Validation Master Plan (VMP).
- Ensure the ongoing auditability of the files in charge.
- Conduct/Lead quality risk analyses
- Define the validation strategy in agreement with the project team
- Draft the validation plan and associated documents
- Coordinate executions
- Draft reports and conclusions
- Develop a partnership with internal clients, internal support services (IT, Metrology, Periodic Inspection), and external suppliers.
- Work in collaboration with the Quality Assurance Department to ensure compliance with applicable regulations, guidelines, standards, and internal procedures (SOPs).
- Participate in internal audits, external audits, and regulatory inspections (national and international authorities, FDA, EMEA, etc.). Report to managing any issues impacting the quality of systems, instruments, or products manufactured and/or under development.
- Make appropriate decisions regarding deviations impacting the qualification/validation strategy.
- Ensure compliance with applicable legislation and HSE regulations.
- Degree in a relevant Engineering Field
- Extensive experience in s similar role
- Experience of large CAPEX project
#LI-CB1
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 QCS Staffing for seven years now and have always received a professional service. QCS Staffing'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 QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. 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
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Chris
I manage this role.