Job Description

Description :

As the Production Manager, you will be responsible for sterile production, inspection and packaging of injectable products on the Candiac site. You will manage a team of 5 people.

Responsibilities:

• Apply and enforce standards in terms of health, safety and the environment
• Plan and organize the utilization of resources including equipment and labour in order to optimize the execution of daily operations and meet the delivery dates of external customers
• Ensure that all equipments are meeting all requirements and are in accordance with procedures
• Respect the standards of efficiency during the maintenance of the premises and/or the preparation of the equipment
• Participate in the preparation and review of the budget
• Manage , resolve and escalate operationnal incidents to respect the production plan
• Participate in the development and implementation of capital investment projects for the production of injectables
• Ensure 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
• Approve procedures, deviations\xc2\xb8 CAPA, and extensions
• Participate in regulatory and customer audits; act as an SME
• Support the internal audit program
• Approve validation protocols
• Approve and sign production batch records
• Respect the production cycle time and assure the availability of products on the market
• Participate in the recall committee when required
• Participate in the validation review board (VRB) when required
• Manage, motivate and develop team members to achieve defined goals
• Proceed with the evaluation of the performance of the employees under his responsibility according to the annual performance objectives set
• Maintain a level of manpower in order to achieve corporate objectives
• Ensure compliance with the employee manual
• Define performance indicators specific to the team such as production rejections, number of deviations, equipment breakdowns, etc. ; see to their implementation and ensure their follow-up
• Optimize production plans
• Establish robust processes
• All other related tasks

Skills, knowledge and abilities:

• High degree of motivation, initiative and creativity
• High degree of motivation, initiative and creativity
• 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
• Very good knowledge of Good Manufacturing Practices and Canadian standards
• Necessary experience in human resources management
• Knowledge of FDA standards
• Mastery of software on Windows environment; SAP, Trackwise
• Excellent French (verbal and written) and good knowledge of English (especially verbal) due to inspection from regulatory authorities from other countries and interaction with clients.

Education : Bachelor
Bachelor

Experience : 5 years: Five to ten years of experience in the pharmaceutical field and Staff management

Pharmascience