Senior Manager, Laboratory Services
1 month ago
Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.
Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.
At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.
Main duties
Ensures the management and execution of quality control analyzes (raw materials, finished products, stability, packaging materials in compliance with quality regulations and GMP standards.
Ensures the management of environmental control analyzes in the factory as part of the environmental monitoring program, microbiological analyzes of raw materials, finished products, stability in compliance with quality regulations
Ensures the management of process validation analyzes
Ensures the conformity of batches and release of products from a quality control point of view
Ensures the management of analytical projects related to product transfers, validation of manufacturing processes, washing methods, analytical methods, laboratory equipment in compliance with regulations and quality standards, against the required deadlines
Ensures that sample collection and execution of quality control analyzes for raw materials, finished products, stability, packaging materials are carried out in compliance with regulations and good laboratory practices
Guarantees the accuracy of the quality control laboratory's analyzes and the verification and documentation of analysis files
Guarantees the conformity and updating of documentation relating to good laboratory operations (specifications, methods, monographs, procedures)
Analyzes malfunctions (investigations, deviations, OOT/OOS); reviews and approves all laboratory investigations; approves the implementation of corrective actions and ensures the treatment of non-conformities until the problem is definitively resolved
Ensures the conformity of batches and ensures the release of products from a quality control point of view
Negotiates the planning of analysis outputs to respect cycle times
Identifies customer needs, develops planning and action plans, evaluates constraints, determines priorities and monitors analytical projects (new references, new formulas, product transfers, optimization of analytical methods, validation of processes and methods of washing)
Manages the completion of analytical projects related to product transfers, validation of manufacturing processes, washing methods, analytical methods in compliance with quality standards
Analyzes deviations and deviations from project implementation, proposes and coordinates corrective actions
Guarantees the development and implementation of documentation relating to products, methods, equipment (validation, qualification, protocols)
Develops, communicates and implements operational objectives for the department, ensuring compliance with corporate objectives
Provides support for activities during analytical transfers and validation of laboratory equipment
Ensures management of the calibration program (metrology) of laboratory equipment
Participates in the definition, implements and monitors the quality program of his department
Ensures compliance with the laboratory equipment calibration system
Ensures the management of official samples and reference substances
Optimizes the laboratory analysis process and batch release time
Ensures compliance with quality regulations in the choice of laboratory equipment and modifications to analytical methods
Guarantees the validation of analytical methods and laboratory equipment (updating and compliance of instructions for use of new laboratory equipment, procedures and analytical methods)
Responsible for training laboratory staff on new equipment and new analytical methods
Ensures follow-up of corrective actions related to requests for changes in his sector
Ensures compliance and application of GMP, GLP and regulatory constraints within his department and in analytical development projects
Manages the implementation of new technologies in the laboratory
External relations (regulatory and customers)
Negotiates the planning of analyzes with production and logistics and ensures monitoring and execution during transfers
Negotiates the adjustment of deadlines with project action leaders and with external suppliers within the framework of projects
Contact person during audits to provide any technical or quality support related to laboratory operations
Ensures expertise in his field (explanations, training, technical support)
Ensures regular information on the progress of projects to user managers of other site services
Management of industrial hygiene analyses.
Respect and apply the HSE policy in your department and in analytical development projects
Participates in the development of the PASS and ensures the implementation of the actions for which he is responsible
Ensures the execution of industrial hygiene tests
Proposes HSE improvements through the PASS and monitors the actions undertaken
Organizes the analysis of incidents/accidents, recommends corrective actions and ensures follow-up
Leads and organizes your team
Set objectives for your colleagues
Appreciates and evaluates the contributions of its collaborators and carries out periodic reviews of the performance of its employees; observes, analyzes, documents, monitors and influences behavior.
Conducts written evaluations of employees, proposes promotions/sanctions, salary increases accordingly
Ensures the development of its employees, particularly through the definition of the training plan
Identifies staffing needs and participates in recruitment, making hiring recommendations
Ensures the effectiveness of the integration and training process within his department
Ensures that you maintain a daily climate conducive to good team productivity
Ensures compliance with human resources policies and promotes the use of the tools made available
Prepares and manages the operating budget of his department
Ensures the monitoring and implementation of investments in its sector
Proposes the annual performance objectives of his department
Manages the operational implementation of quality projects or transfer projects
Manages staffing and equipment allocation priorities based on needs and deadlines
Proposes organizational solutions to improve performance within its scope of responsibility
Ensures deadlines are met and informs the relevant departments in the event of deviations
Provides support for validation activities (methods, equipment, new products)
Organizes and provides resources for the successful completion of project actions
Defines action plans allowing the optimization of the activities of his department in terms of quality, costs, deadlines
Main professional relationships
Proposes meetings with internal customers or peripheral services and defines action plans to optimize analyzes in terms of deadlines and costs
Promotes exchanges between departments to achieve the site’s objectives
Ensures permanent liaison with operational services to obtain/disseminate information related to product quality control
Is the preferred contact for production, QA, logistics, supply chain services, for the management of daily problems related to product quality control
Provides an advisory/expert role when resolving analytical problems on a daily basis
Ensures deadlines are met and informs the relevant departments in the event of deviations
Internal partners: Production, purchasing, planning, quality assurance, compliance, analytical department, supply chain departments for the management of daily issues related to quality control of products
External partners: QC contact during audits, laboratory analysis service providers, external customers, etc.
Knowledge and skills required:Bachelor's or Master's degree in Chemistry, Microbiology, Pharmacy or biological sciences
5 to 10 years of experience in Quality Control – Chemistry / Microbiology
Knowledge of the production of pharmaceutical products and Canadian and international GMP/GLP standards.
3 to 5 years of management experience in a quality control laboratory
Excellent technical knowledge
Member of the Order of Chemists of Quebec
Technical, regulatory
GMP and relevant benchmarks/activities
Document Management
LEAN (six sigma) manufacturing principles, Shingo
Languages: French and English
The masculine is used in this publication without prejudice for the sake of conciseness.
Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
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