Field Compliance Coordinator

2 weeks ago

Canada Pharmascience Inc. Full time
Manufacturing
Full-Time
The 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.

Responsible for management of technical support team, problem resolution and process improvement activities for marketed products for Candiac site.

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.

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.

Participates in regulatory and customer audits; Supports the internal audit program.
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.
Ensures coordination with support sectors when necessary; during the implementation of new products, new equipment and/or problem solving.

Technical knowledge in aseptic processes in Injectables
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
Knowledge on Windows environment; SAP, Trackwise
Bilingual - French and English (communication with customers mainly based in the USA)
Bachelor or better in Génie chimique - Chemical Engineering or related field.
Bachelor or better in Science or related field.
of experience in the pharmaceutical field specifically in aseptic injectables Experience in a sterile environment

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