RESPONSABILITIES & DUTIES Approve procedures, notices of change, capa, deviations and extensions Participate in regulatory and client audits. Act as SME. Support the internal audit program Approve validation protocols Signing batch records Respect of cycle time and availability of products on the market. Participate to the recall committee when required. Participates to the validation review board (VRB) when required. To verify integrity of their own analysis results
WORKING CONDITIONS & PHYSICAL ENVIRONMENT
Laboratory work, ability to work under pressure to meet deadlines.
SKILLS, KNOWLEDGE & ABILITIES Agility, strong focus on results and customers. Ability to communicate openly, clearly and transparently at all levels, in writing as well as orally. Collaboration and openness decisions. Exemplary and positive attitude – motivated by the mission and company’s values. Accountability to the facts and acts. Ability to analyze problems, planning and efficient organization, teaching ability. Creativity and ability of innovation. Resourcefulness and stress resistance. Bilinguism is an asset. Knowledge of current laboratory technologies. Familiar with the guidelines of Good Laboratory Practices (GLP). Knowledge of the pharmaceutical field and guidelines. Fluency in the use of Empower II software (Waters), LIMS (Labware) and Microsoft Excel and Word
Diploma of College Studies or better in Biochimie - Biochemistry or related field.
Diploma of College Studies or better in Chimie - Chemistry or related field.
Bachelor or better in Biochimie - Biochemistry or related field.
Bachelor or better in Chimie - Chemistry or related field.
Licenses & Certifications