Spécialiste Systèmes Qualité/Quality Systems Specialist

KABS•Longueuil, QC

94d•Onsite

About The Position

The person entitled will have the primary responsiblity of writing and executing equipment / systems qualification protocols for the production plant and will be responible for maintaining the requalification plan as per the master validation plan.

Requirements

Technical or university degree in mechanical engineering, pharmaceutical or chemical production, with experience in the pharmaceutical industry (an asset)
Experience with standard laboratory and pharmaceutical production equipment
Knowledge of GMP or ISO 13845
Autonomy, resourcefulness, meticulousness, sense of detail

Nice To Haves

The perfect candidate is passionate about the pharmaceutical industry and has a continuous desire to learn and to perform in his job. He is professional and a hard worker. The candidate cares about health and scientific innovation. He loves challenge and wants to develop his skills in a stimulating environment.

Responsibilities

Qualify production and laboratory equipment (blender, press, balance, etc) according to the Master validation plan
Qualification and daily monitoring of system performance (compressed air, HVAC, purified water)
Follow-up / participate in preventive maintenance activities
Participate in the writing of qualification protocols
Participate in the drafting of standard operating procédures
Write equipment cleaning procedures
Participate in the validation of packaging processes, manufacturing, etc.
Participate in the monitoring of environmental data of the production areas (temperature mapping, particle testing, etc.)
Initiate reports of OOS, deviation, CAPA, etc. related to equipment or qualification activities
Actively participate in the improvement of the department (implementation of new procedures, way of working forms, etc.)