Head of Qc

il y a 15 heures

Brussels, Belgique CordenPharma Brussels Temps plein

Brussels, BE

**Our Company**:
CordenPharma is a leading Contract Development & Manufacturing (**CDMO**) partner with approximately 2’000 employees across Europe and the United States and annual revenues > 500 M€, enabling pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier lives.

Founded in 1987, CordenPharma Brussels, formerly Peptisyntha, was a member of the Solvay group until being acquired by CordenPharma in October 2013. CordenPharma Brussels has built a 30-year track record of success in supplying pharmaceutical and biotech companies with clinical and commercial scale **cGMP peptide APIs**.

Through expertise and capabilities in all synthetic peptide-manufacturing technologies, CordenPharma Brussels assesses and customizes its manufacturing approach to achieve the most effective manufacturing process for its customers.

**Function description**:**The Head of QC **will be working as part of the Quality department ensuring products are manufactured, stored and packaged in accordance with cGMP rules.

He / she will be responsible for ensuring timely, accurate completion of QC testing performed both in house and at vendors.
In addition, the Head of QC 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 Head of QC is reporting to the Quality Affairs Director of Corden Pharma Brussels.

**Main activities**:

- Management up to 20 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 & first time right 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
- Implementing the new analytical methods after development phase done by R&D team (review and approve validation documentation)
- 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 in collaboration with the site Operational Excellence Lead
- Ensuring budget follow-up
- Ensuring good relationship with internal and external stakeholders

**Desired Skills and Experience**:

- University degree in a scientific discipline with analytical background is mandatory (Chemistry is an asset)
- 8 years with 5 years in a similar role in the pharmaceutical industry (API in CDMO companies is an asset)
- Strong laboratory skills and good knowledge of analytical chemistry
- People management experience (Leadership experience)
- Strong problems solving skills, issue resolution and root cause analysis
- Very good knowledge of cGMP in a regulated environment (US and Eur)
- 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.
- Language : needs to effectively communicate in French and English (oral and written)

**Interested?

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