PolyPeptide Laboratories est une entreprise high-tech spécialisée dans le développement, la production, et la vente de peptides actifs thérapeutiques.
PolyPeptide basée à Braine-l'Alleud est à la recherche d'un QC KI and API Team Leader, pour le département QC / API
Nature and scope :
The release of Key intermediates and Active Pharmaceutical Ingredients (API).
To Manage the team, equipment and activities in a cGMP context in order to meet the objectives defined by the organization.
Activités principales :
Responsible for performing cGMP compliant analysis:
- Releases of KI and API
- The release responsibility of the Team Leader is backuped by others Team Leader
- The specific responsibilities of the Team Leader (deviation, CAPA, OOT, NCP,… ) are backuped by others Team Leader of the QC Department
- Responsible to maintain the laboratory compliance level with cGMP, HSE and to promote continues improvement
- Responsible of team management (onboarding, training, development, evaluation, organisation, ….) with a presence in the field compound
- Representative for audits and inspections
- Responsible for analytical methods transfer
- Responsible for the RS (stocks and validities)
- Responsible of the LIMS specifications
- Responsible for testing planning in relation with overall site Planning
- Responsible to participate to scientific discussions in order to assess the quality attributes of the KI and API
- Responsible of the quality documentation into Qumas (Deviation, CAPA, Change Control, methods, reports, protocols, ...), investigation and OOT, NCP
- Responsible of Key performance indicator for his team
Profil requis :
Master in Sciences with minimum 5 year experience in pharmaceutical industry
- Strong expertise in GMP and regulatory
- People management (Listening ability, motivating & training others, team player, leadership, initiative spirit,…)
- Sense of organisation and planning
- Effective communication
- Scientific knowledge of different analytical techniques ( HPLC, GC, TLC, pH, Karl-Fischer, UV, IR, Titration, CHN, RI,…)
- Results focus and positive attitude
- Fluency in French and English
- Skill in IT system (should be able to use and to manage a LIMS system, a Document management system, a Chromatography Data System and other common Microsoft software)
PolyPeptide offers an informal, dynamic and exciting work environment with a good opportunity to work with a broad variety of tasks within the dedicated department. You will be working closely with the other departments of PolyPeptide.
In the PolyPeptide Group, we strive to work together as one team.
What we offer is :
- a full time contract
- an attractive salary
- an extra-legal benefits and insurances
- a company car and fuel card
- a challenging position in an innovative and dynamic work environment with an open culture.