Job Description
Job Category:Manufacturing Requisition Number:CHEFS003034 Apply now Posted : April 2, 2024 Full-Time LocationsShowing 1 location DescriptionThe Technical services Manager is responsible for all activities supporting the production of injectables at the Candiac site. This role is responsible for the application of policies and standard operating procedures in regard to cleaning, process validation, process improvement, sterility assurance including the visual inspection program, qualification & requalification of critical sterilization equipment (lyo, autoclave, beadmill). He has the technical knowledge to support operations in terms of approval of master batch records, change control, CAPA, CPV, protocols and troubleshooting while maintaining a good relationship with internal and external customers. He also acts as a Subject matter expert (SME) during regulatory and clients’ audits. Material Resource Management: Responsible for management of technical support team, problem resolution and process improvement activities for marketed products for Candiac site. Applies and enforces standards in terms of health, safety and the environment. Plans and organizes the utilization of resources including equipment and labor in order to optimize the execution of operations support and meet the delivery dates for external customers. Ensures that all equipment, cleaning methods and manufacturing processes meet all requirements and are in accordance with procedures. Participates in the preparation and review of the budget. Manages, resolves and escalates operational incidents in order to respect the production plan. Responsible for the escalation when there is qualification fail or major deviations on qualified equipment (VRB). Establishes and follows the sterility assurance program for Candiac operations including production, quality and Scientific Affairs. Reinforces the knowledge of site around injectables processes. Support strategic projects in terms of expertise for the new technologies and apply the validation master plan for critical equipment. Quality and compliance management: Ensures that the operations are described in the procedures and that these conform with Good Manufacturing Practices (GMP), as well as Canadian, American and European standards. Approves protocols, reports, deviations ¸ CAPA, and extensions. Participates in regulatory and customer audits; acts as an SME. Supports the internal audit program. Approves and signs master batch records. Participates in the recall committee when required. Participates and host the Candiac validation review board (VRB). Chairs the defect review board. Human Resource Management: Manages, motivates and develops team members to achieve team goals. Is responsible for the performance management of the employees under his responsibility and ensures set objectives are delivered. Applies and ensures compliance with health and safety rules; develops health and safety culture at plant level. Defines performance indicators specific to the team. Optimizes current processes and establishes new robust ones. Cross-sector coordination: Ensures coordination with support sectors when necessary; during the implementation of new products, new equipment and/or problem solving. Skills, knowledge and abilities: Technical knowledge in aseptic processes in Injectables Action oriented Excellent communication and interpersonal skills; able to deal with all hierarchical levels Patience, diplomacy, and sensitivity to customer needs Ability to manage priorities and be results-oriented Autonomy, a great sense of organization, a great ability to manage and coordinate several projects and/or tasks simultaneously as well as good resistance to stress Cost/budget management Knowledge on Windows environment; SAP, Trackwise Bilingual - French and English (communication with customers mainly based in the USA) QualificationsEducationRequiredBachelor or better in Génie chimique - Chemical Engineering or related field. Bachelor or better in Science or related field. ExperienceRequired5 years:5 years:of experience in the pharmaceutical field specifically in aseptic injectables Experience in a sterile environment Leadership and human resources management Very good knowledge of Good Manufacturing Practices and Canadian standards#J-18808-Ljbffr