QA Team Coach (m/f)
QA Team Coach (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. Further information can be found at: www.mithra.com
Mithra Pharmaceuticals is looking for a QA Team Coach to join its QA department in Flémalle.
The Quality Assurance Team Coach is responsible for managing the activities of QA Technicians, supervising quality assurance activities on the Value Stream while working closely with the production to ensure compliance with the cGMP and continuously improve processes.
Duties and Responsibilities
Responsible for the quality operations related to a stream value
- Responsible for the QA batch review and approbation
- Ensures batches related to the area of responsibility are released in a timely manner
- Ensure Internal document approval (e.i.: MIDF, CAPAs, Deviations, SOPs) in timely manner
- Review and support deviation investigation, change control related to operations related to the value stream
- Ensure the adequate management of validation deviation (be QA GMP responsible) and potentials CAPA (be Compliance Authority)
- Ensures critical topics are adequately and timely escalated to higher management
- Responsible to Review the PQR
- Review and approve specific qualification and validation documentation (URS, DR, IQ, OQ, equivalence certificate, PQ, PV and requalification documentation) and ensure that they are written in accordance with standards and procedures
- Review and approve operational SOP
- Support the QA release for complaint investigation and product impact analysis
- Provide operational support with timely effective feedback on compliance or event issues.
- Participate in production tier meeting and shop floor to ensure adequate QA oversight / continuous improvement
- Ensures quality oversight of all activities related to the area of responsibility
- Lead QA tier meeting for their VS
- Double check (after the production) that all system used in the VS are validated
- Perform audit of the VS to ensure compliance with cGMP
- Prepare quality KPIs for the VS
- Bachelor or Master in Sciences, Pharmacy
- Minimum 5-10 years of previous experience in a QA Department
- Strong knowledge of USA and EU GMP, ICH guidelines, and European and United State pharmacopeias
- Focus on continuous improvement
- Leadership skill, providing knowledge, experience, motivation, support and advice to the 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
Send your CV and application letter via button POSTULER.
Your email must mention following subject: CDMO-QATC-082018
Recruitment Agencies, please refrain from contacting us or sending us CVs on a spontaneous basis