For one of our clients located in Brussels we are curently recruiting for a full time role :
Quality Control Manager
- Do you have an University degree in a scientific discipline with analytical background?
- Do you have 8 years experience with 5 years in a similar role in the pharmaceutical industry?
- Are you French and English speaker?
Then this could be a job for you! Read more and apply as soon as you can!
As Quality Control Manager you will be working as part of the Quality department ensuring products are manufactured, stored and packaged in accordance with cGMP. You will be responsible for ensuring timely, accurate completion of QC testing performed both in house and at vendors.
In addition, you will provide strategic input regarding lab organization and structure.
Under the direction of the reporting manager, you will continuously strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.
Main responsibilities / Major Activities
- You will manage up to 10 QC chemistry and microbiology team members: (staff support, coaching, training and recruitment)
- You will ensure follow-up of day-to-day activities, supervising implementation and progress of the QC activities
- You will manage SOPs, change controls, deviations, OOS and CAPA
- You will ensure smooth running of the lab: on-time & GMP-compliant analyses; housekeeping of the lab
- You will develop and/or review departmental documentation including test methods, SOP’s, protocols and reports ensuring compliance with cGMP and applicable regulatory guidelines
- You will validate Analytical methods : you need to be able to set up and write validation protocol , to analyze the validation results and provide conclusion , to release the validation report
- You will implement and validate the new analytical methods after development phase done by R&D team (you will write validation protocol, analyze the validation results and provide conclusion )
- You will manage stability studiesand interpret results
- You will review and Approve analytical dossiers
- You will be in contact with external customers for QC related issues
- You will be responsible for QC Release of raw materials, intermediates products and finish product
- You will provide technical support during customer audit and regulatory inspections (FDA, AFMPS, other)
- You will coordinate laboratory equipment acquisition, qualification, calibration and preventative maintenance.
- You will lead QC optimization processes and Operational Excellence QC project
- You will ensure budget follow-up
- You will ensure good relationship with internal and external stakeholders
- You have an University degree in a scientific discipline with analytical background (Chemistry is an asset)
- You have 8 years experience, with 5 years in a similar role in the pharmaceutical industry (API is an asset)
- You have strong laboratory skills and good knowledge of analytical chemistry
- You have people management experience (Leadership experience)
- You have strong problems solving skills, issue resolution and root cause analysis
- You have a very good knowledge of cGMP in a regulated environment (US and Eur)
- You have experience with guidelines , standards (ICH, Pharmacopea, 21CFR part 11)
- You have experience with regulatory inspection (FDA and AFMPS)
- You have proven ability in prioritizing according to the needs
- You are strongly quality and service minded
- You are customer oriented, team player, focused on improvement
- You have excellent interpersonal skills
- You have working knowledge of computer packages (Word, Excel, MS Project, Visio, Power Point)
- You are able to work independently in a fast paced multitasking environment.
- You are French and English speaker