Job Description

Description :
Supervise sterile production activities to meet regulatory standards while monitoring production planning. Responsible for monitoring SOP procedures and corporate policies and procedures. Maintain a compliant environment and ensure the quality and sterility of the products filled under its supervision. Ensure the qualified status of equipment, premises and staff is maintained. Participate in investigations. Perform the review of batch records and ensure the training of employees under his responsibility. Participate in the preparation of the budget.
Responsabilities & Duties :
Material Resource Management:

• Apply and enforce standards in terms of health, safety and the environment
• Plan and organize the use of resources including equipment and labor to optimize the execution of daily operations and meet the delivery dates of external customers;
• Ensure that all equipment is in good operating condition according to procedures;
• Respect the standards of efficiency, cleanliness during the cleaning of production areas and / or preparation of equipment;
• Manage and resolve any emergency situation in order to respect the production plan

Quality and Compliance Management:

• Ensure that the operations as a whole are performed as described in the procedures and that they comply with Good Manufacturing Practices, as well as Canadian, US and European standards;
• See the management and updating of production documents according to the systems and procedures in place.
• Write the procedures, notices of change, CAPA, deviations and extensions
• Participate in regulatory and client audits. Act as SME
• Support the internal audit program
• Revise the batch records, SAP consumption
• Ensure respect of cycle time and availability of products on the market.

Human Resource Management :

• Manage, motivate and develop team members to achieve defined goals
• Evaluate the performance of the employees under his responsibility according to the annual performance targets set.
• Maintain a level of manpower to achieve corporate objectives.
• Ensure compliance with the employee manual
• Apply and ensure compliance with Health & Safety rules. Develop a health and safety culture at the plant level

Management of continuous improvement:

• Define team-specific performance indicators such as production rejects, number of deviations, broken equipment, etc. ; see to their implementation and ensure their follow-up.
• Optimize production plans
• Establish robust processes

Inter-sector coordination:

• Coordinate with the "Support" sectors when necessary, among other things, when implementing new products, equipment and / or problem solving.

Skills, knowledge & Abilities :

• High degree of motivation, initiative and creativity;
• Excellent communication and interpersonal skills. ;
• Patience, diplomacy and sensitivity to customer needs;
• Ability to manage priorities and focus on results;
• Autonomy, a great sense of organization, a great ability to manage and coordinate several projects and / or tasks simultaneously as well as a good resistance to stress;
• Mastery of software on Windows environment; SAP, Trackwise
• Excellent knowledge of French (oral and written) and good knowledge of English (especially oral). The supervisor will collaborate with Regulatory authorities oustide of Quebec.

Education : Bachelor
Experience : 5 years: Five years of experience in the pharmaceutical industry. o Experience in a sterile environment o Required experience in human resources management, o Very good knowledge of Good Manufacturing Practices and Canadian Standards o Knowledge of the standards of the F.D.A.

Skills Required