Analytical Development QC Technician (m/f)
Analytical Development QC Technician (m/f) Company
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 an Analytical Development QC Technician to join its QC department in Flémalle.
The Analytical Development QC 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
- Develop and optimize analytical methods to analyze drug substances and drug products
- Perform and confirm that raw materials, in process goods and final products are manufactured to desired specifications and in accordance with the requirements of the company and the site, and the regulations in terms of safety, environment and quality for the R&D analyses.
- Develop and perform the laboratory tests requested by the Production and R&D Departments
- Take place at the development, pre-validation and transfer of analytical methods
- Realize stability and API & excipients control analyses in respect with quality and security norms for the R&D Department in order to develop new drugs
- Perform laboratory tests in compliance with quality and safety rules and applicable procedures.
- Perform laboratory work and tests according to defined standards and based on a thorough understanding of operating procedures and equipment protocols.
- Operate, adjust, calibrate and qualify laboratory equipment and instruments.
- Maintain accurate and precise records of all laboratory analyses using appropriate record keeping and documentation processes.
- Able to critically interpret and scientifically justify the obtained results and make a relevant conclusion.
- Write procedures, protocols, reports and other controlled documents necessary for the analytical tests or the qualification of equipment.
- Be critical to solve or optimize laboratory analyses
- Essential functions require to be present in the workplace on a regular basis and an ability to work extra hours if needed. Overtime may occasionally be needed 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
- Graduate level in chemistry with minimum 3-5 years of previous experience in a R&D laboratory
- Applied knowledge of analytical chemistry
- Strong knowledge of GMP and GLP regulations, ICH guidelines, EP/USP/JP pharmacopeias is an asset
- Theoretical and applied knowledge in HPLC/UPLC systems with good knowledge of Empower software
- Focus on continuous improvement
- Self-motivated and pro-active within a team
- Autonomous and flexible
- Strong communication and social skills
- Solutions oriented
- Good knowledge of French and English (oral and written). Any other language is an asset
- Good knowledge of Microsoft office
What we offer
Varied and motivating responsibilities within a fast growing company
An attractive salary package in line with your experience
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Your email must mention following subject: CDMO-QCA-072018
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