Process Validation Specialist
Bruxelles Nord – CDI
#Process #validation #job #specialist
You have a first experience in pharmaceutical company? You are an efficient person? You can handle different projects simultaneously owing to your organizational skills? Keep reading your future job description.
Our partner is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, our partner has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.
For the sterile production site located in Belgium in Brussels (Neder-Over-Heembeek) which is currently expanding its capabilities, we are currently looking for a Process Validation Specialist: you will act as an expert for the validation of processes and support in QbD assessments (Quality by Design). You will also be involved in other activities, related to the process (cleaning, MFT) and to the manufacturing equipment’s (qualification). The Process Validation Specialist reports to the Qualification & Validation Aseptic Leader
What are your responsibilities?
To be successful as Process validation Specialist, here are your tasks:
- Ensure that all qualifications and validations are performed according to the regulatory and customer requirements
- Be able to support Quality by Design on the drugs to be transferred or developed on the site
- Write qualification and validation protocols/reports and other documentation related to the activities
- Based on the deduced CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters) be able to develop the appropriate validation plan
- Be an expert for the validation of aseptic process (formulation, filling, holding times)
- Participate to shutdown qualification & calibration activities
- Investigate deviations as needed and execute corrections
- Define and execute improvement projects and initiatives
- Participate in customer and authority audits
- Can be involved in other process validation activities
- Ensure that all activities are performed in time and due quality
Who are you?
- Minimum of 3 years of experience in the pharmaceutical industry, with 3 years in a validation role or a similar position
- Experience in Quality by Design is an asset
- Maturity in the role
- Positive energy and mind-set
- Excellent communication skills are desirable
- Fluency in French and English is required
What can you expect?
- What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry – a sterile business
- Potential for personal development within an international company
- Defined career path and annual performance review and feedback process
- Contributory pension and benefits package all offered from day one of employment
- 36 days’ holiday + bank holidays
You’re interested in this job? We kindly invite you to apply directly on our website. Do you have questions? You can contact Dimitri Soupart : [email protected]