QC Physico-Chemistry Lab Leader (m/f)
Mithra Pharmaceuticals SA, founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart, is a Euronext listed pharmaceutical company (MITRA) focused on Women’s Health. Mithra’s mission is to improve every stage of women’s life with innovative and accessible pharmaceutical solutions. As such the Company aims to become a worldwide leader in women’s health by developing, manufacturing and commercialising proprietary, innovative and differentiated drugs and complex therapeutical solutions in four therapeutic fields of women’s health: fertility and contraception, menopause and osteoporosis, gynecological infections and female cancers.
Mithra Pharmaceuticals is looking for its integrated technology platform (R&D/Production) based in Flémalle for a QC Physico-Chemistry Lab Leader.
He/She will lead a team in charge of supporting the activities of the QC physico-chemistry lab. He/she will organize the sampling and handling of analytical samples, manage the documentation such as analytical batch records and SOPs, supervise the reviewing of analytical tests and the follow up of deviations and CAPA.
The QC physico-chemistry leader will report to the Quality Control manager.
Duties and Responsibilities :
- Ensure follow-up of day to day lab activities and supervise the execution in compliance with quality and safety standards.
- Reviewing analytical tests
- Writing, reviewing and improving documentation system in QC lab
- Ensuring compliance of analytical activities with GMPs and local SOPs
- Organizing stabilities studies (planning, protocols, deviations) with the collaboration of the QC Manager
- Assure successful transfer, validation and/or verification of analytical methods.
- Managing SOPs, change controls, deviations and CAPA
- Participating in investigations (root cause analysis)
- Coaching the lab team, supporting and motivating staff, taking care of trainings
- Responsible of sample management and cleaning process of the lab
- Supporting the QC manager in case of audit and inspections activities
- Leading QC optimization processes
- Master in Pharmaceutical Sciences or Chemistry (PhD is an asset) with 5 years relevant experience in pharmaceutical QC GMP physico-chemistry lab.
- Strong knowledge of GMP and GLP regulations, ICH guidelines, EP/USP/JP pharmacopeias
- Excellent knowledge of French and English (oral and written). Any other language is an asset.
- People management skills (leadership experience)
- Applied knowledge of analytical chemistry and statistics tools.
- Strong knowledge in HPLC/UPLC/GC systems with good knowledge of Empower software
- Technical skills: PSD, FT-IR, UV, DSC…
- Focus on continuous improvement
- Self-motivated and pro-active within a team
- Autonomous and flexible
- Strong communication and social skills
- Solutions oriented
What we offer :
Varied and motivating responsibilities within a fast growing company
An attractive salary package in line with your experience
Send your CV and application letter via button POSTULER. Your email must mention following subject: CDMO-QCL-122016.
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