QC Physico-Chemistry Technician (m/f)
QC Physico-Chemistry Technician (m/f)
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in women’s health, with a particular focus on fertility, contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its two lead development candidates – a fifth generation oral contraceptive, Estelle®, and a next generation hormone therapy, Donesta®- are built on Mithra’s unique natural estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its Mithra CDMO.
Mithra was founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra has an approximate headcount of 200 staff members and is headquartered in Liège, Belgium.
Mithra Pharmaceuticals is looking for a QC Physico-Chemistry Technician for its integrated technology platform (R&D/Production) Mithra CDMO based in Flémalle.
The QC Physico-chemistry Technician is responsible for testing and confirming that material and in process goods are manufactured to desired specifications and in accordance with company and site requirements and applicable safety, environmental and quality regulations.
Duties and Responsibilities
- Analyze raw materials, in process goods and finished product to ensure product quality and specifications are met
- Perform laboratory tests or other laboratory work using conventional and computerized machines
- Perform laboratory work and tests according to prescribed standard
- Set up, adjust and operate laboratory equipment and instruments
- Perform tests and assay via thorough understanding of laboratory standard operating procedures and instrumentation.
- Use principles and theories of sciences to solve technical problems
- Maintain accurate and precise records of all laboratory analysis using appropriate record keeping and documentation processes.
- Maintain compliance with quality system
- Assist in any non-routine work needed to solve plant quality problems.
- Calibrate test equipment, reports and maintains historical records of all testing performed
- Essential functions require presence in the workplace on a regular basis and an ability to work extra hours if needed. If applicable, ability to work overtime may be needed to ensure required shift staffing capacity to meet daily production objectives
- Work collaboratively with team members with different backgrounds and perspectives
- Participate in Environmental, Health & Safety initiatives as set forth by the company
- Participate in and complete company required training programs
- Redaction of documents: SOP, protocols and reports
- Graduate level in chemistry with minimum 1-2 years of previous experience with GMP QC physico-chemistry lab
- Applied knowledge of analytical chemistry
- Knowledge of GMP and GLP regulations, ICH guidelines, EP/USP/JP pharmacopeias
- Knowledge in HPLC/UPLC/GC systems with knowledge of Empower software
- Technical skills: FT-IR, UV, KF, Dissolution…
- Focus on continuous improvement
- Self-motivated and pro-active within a team
- Autonomous and flexible
- Strong communication and social skills
- Solutions oriented
- Excellent knowledge of French and knowledge of English (oral and written).
Any other language is an asset
- Good knowledge of Microsoft office
- Must be able to work rotating shifts
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-PCT-082018
Recruitment Agencies, please refrain from contacting us or sending us CVs on a spontaneous basis