Corden Pharma is an expert Contract Manufacturing partner, enabling pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier lives. Formed as a pharmaceutical branch of International Chemical Investors Group (ICIG) in 2006, Corden Pharma provides specialized technologies, grouped under six technology platforms that are ideal for the development and manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients, and associated Global Supply Chain and Packaging Services. As a full-Service CDMO for the global market, Corden Pharma is committed to bringing inspired global service and flexible solutions, spanning the entire pharmaceutical product continuum. The company’s chemists and engineers are widely recognized for their history of innovation, having developed highly efficient manufacturing processes for some of the world’s most complex pharmaceutical compounds.
With multiple cGMP compliant facilities across Europe and the United States, Corden Pharma is the flexible, efficient, and cost-effective solution for all contract manufacturing needs.
For our Peptide API manufacturing subsidiary located in Brussels, Belgium we are currently looking for a qualified
QC Manager (f/m)
The QC Manager will be working as part of the Quality department ensuring products are manufactured, stored and packaged in accordance with cGMP.
He / she will be responsible for ensuring timely, accurate completion of QC testing performed both in house and at vendors. In addition, the QC manager provides strategic input regarding lab organization and structure. Under the direction of the reporting manager, 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.
The QC manager is reporting to the Head of Quality of Corden Pharma Brussels.
- >> Management up to 12 QC chemistry and microbiology team members: (staff support, coaching, training and recruitment)
- >> Ensuring follow-up of day-to-day activities, supervising implementation and progress of the QC activities
- >> Managing SOPs, change controls, deviations, OOS and CAPA
- >> Ensuring smooth running of the lab: on-time & GMP-compliant analyses; housekeeping of the lab
- >> Develop and/or review departmental documentation including test methods, SOP’s, protocols and reports ensuring compliance with cGMP and applicable regulatory guidelines
- >> Validation of Analytical methods : need to be able to set up and write validation protocol , to analyze the validation results and provide conclusion , to release the validation report
- >> Implementing and validating the new analytical methods after development phase done by R&D team (write validation protocol, analyze the validation results and provide conclusion)
- >> Stability studies management and results interpretation
- >> Review and Approval of analytical dossier
- >> Contact with external customers for QC related issues
- >> QC Release of raw materials, intermediates products and finish product
- >> Technical support during customer audit and regulatory inspections (FDA, AFMPS, other)
- >> Coordinate laboratory equipment acquisition, qualification, calibration and preventative maintenance
- >> Leading QC optimization processes and Operational Excellence QC project
- >> Ensuring budget follow-up
- >> Ensuring good relationship with internal and external stakeholders
Minimum experience required:
- >> 8 years with 5 years in a similar role in the pharmaceutical industry (API is an asset)
- >> University degree in a scientific discipline with analytical background is mandatory (Chemistry is an asset)
- >> Language requirements: English (written and spoken), French
Specific competences required:
- >> Strong laboratory skills and good knowledge of analytical chemistry
- >> Very good knowledge of cGMP in a regulated environment (US and Eur)
- >> People management experience (Leadership experience)
- >> Strong problems solving skills, issue resolution and root cause analysis
- >> Experience with guidelines , standards (ICH, Pharmacopea, 21CFR part 11)
- >> Experience with regulatory inspection (FDA and AFMPS)
- >> Proven ability in prioritizing according to the needs
- >> Strong quality and service minded
- >> Customer oriented, team player, focused on improvement
- >> Excellent interpersonal skills
- >> Working knowledge of computer packages (Word, Excel, MS Project, Visio, Power Point)>
- >> Able to work independently in a fast paced multitasking environment
If you are seeking a new challenge in an international and dynamic environment, please send your CV including references and cover letter as well as your salary expectations and earliest availability.