Quality Control Manager
Saint Victor, FR
Technical Expertise
Participates in investigations concerning product quality
Manages out-of-specification and out-of-trend results
Approves specifications, sampling instructions, test protocols and methods, validations and other Quality Control procedures
Responsible for checking quality, carrying out all tests, and reviewing and assessing analytical files on raw materials, packaging items, semi-finished products and finished products
Responsible for laboratory's regulatory compliance and equipment qualification plus validation of analytical methods
Provides analytical support for process validation and cleaning validation activities
Informs the QA Manager and site management of any non-conformity of PM, AC, PSO and PF
Handles products classified as narcotics (RM and FP) as part of the sampling, control and storage operations.
Management
- Based on the needs of internal customers (production, development, etc.), plans and sets priorities for the department.
- Manages the sample library
- Monitors and controls commercialized batches and ICH stabilities
- Carries out assignments or studies assigned by management in connection with the department's operations
- Manages the operating budget
- Manages the department's investments
Personnel Management
PERSONNEL MANAGEMENT
- The QC Manager defines the organization and objectives of the department and its staff and ensures that they are achieved through annual interviews
- Proposes an annual training and development plan for the department's staff
- Ensures that each member of the department has the required level of training for their position
- Prepares recommendations for promotion, training or disciplinary action
- Ensures regular communication with line management
- Leads, motivates and mobilises staff
Qualifications
Pharmacist + 3rd cycle Chemistry-Analytics or Chemical Engineer
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Skills and Experience
Knowledge: GMP, GLP, IT (Microsoft office automation tools, EDM, LIMS, SAP), quality control standards and analysis methods (European Pharmacopoeia, analytical validation), laboratory equipment and measuring instruments.
Experience: minimum 7 years in Quality Control and a minimum of 3 years in a management position.
Technical Skills
- Investigation and root cause analysis techniques
- Internal and external audit techniques
- Strategic planning
- Continuous improvement
Languages
English