Cleaning Validation Manager

Under the responsibility of the Director of Technical Services, the Cleaning Validation Manager manages the cleaning methods validation of Pharmascience plants.

Responsibilities:

PERSONNEL AND BUDGET MANAGEMENT

• Hire personnel and obtain the required approvals.
• Plan and monitor the training of new employees.
• Manage staff performance, including disciplinary management.
• Plan work organization to ensure the team's smooth operation.
• Manage deadlines and set priorities.

COMPLIANCE AND AUDIT MANAGEMENT

• Ensure that the work of the cleaning validation department is done in compliance with current standards.
• Participate in audits as a validation expert.
• Manage audit observations for Validation.
• Manage CAPA and investigations for Validation.

MANAGEMENT OF TASKS SPECIFIC TO CLEANING VALIDATION

• Supervise and manage the cleaning validation methods of PMS plants, as well as requests from various departments.
• Coordinate work with the planning, production, quality assurance departments, and QC & RD laboratories.
• Review and approve all validation documents, protocols, reports, and investigations.
• Manage internal cleaning changes (cleaning method, detergent, introduction of new equipment, etc.).
• Manage documentation related to validation activities.
• Participate in Validation Review Board (VRB) meetings if required.
• Draft validation documents as needed (programs and procedures).
• Participate in various working groups for problem resolution as needed: Change control, Investigation, etc.
• Compile and communicate project progress and results

Skills, Knowledge and Abilities:

• Bilingual in English/French (oral and written)
• Demonstrated skills in managing and developing personnel and high-performing work teams
• Strong planning and budget management skills
• Highly developed situational leadership
• Knowledge of local and international regulatory requirements, standards, and Quality management systems
• Ease of interaction and excellent communication skills
• Autonomy and ability to manage multiple tasks simultaneously
• Problem-solving skills
• Proficient with MS Office, SAP, LIMS, SharePoint