GERENTE DE CONTROLE DE QUALIDADE

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om We are searching for the best talent for GERENTE DE CONTROLE DE QUALIDADE to be in Sao Jose dos Campos, Brazil Purpose.
The Manager, Quality Control will be responsible for carrying out in accordance with GxP chemical, microbiological and physical quality control tests for raw materials, packaging materials, environment/utility, in-process, intermediate, final product and stability samples, when applicable.
Manager will be in charge and/or involved, but not limited to the following processes.
Product release, Retention samples management, Sampling, Lab Quality Performance Management Review, CAPA, Document Control, Stability, Environmental Monitoring, Regulatory Affairs related activities and Inspections.
You will be responsible for.
Responsible for management and accountability for all laboratory operations at the local site.
entors, coaches, trains and develops his/her team.
Evaluates performance, provides opportunities for growth and develop high-performance team (e.
.
meet the targets using SmartQC, build talent pipeline etc.) feeding targeted succession planning.
Acts as change agent and builds and maintains team capabilities to meet current and future needs.
Is responsible for setting the goals and objectives for the department and to define proper Key Performance Indicators that are indicative for excellent performance.
Fosters result driven performance and holds team accountable.
Manages the budget of the group and provide inputs for the OPEX and CAPEX budget, ensures an aligned planning with other team and allocations out for the costs related to her/his team.
Responsibility for achieving innovation and excellence in business processes applying Faster Forward and BEx principles and tools.
Ensure all forecast testing is in line with the timelines, resources and team-budget.
Manages implementation of test methods, new technologies, training and procedures Is subject matter expert and has a leading role during the GMP inspections.
Review and authorize GMP documentation.
Participate in Management meetings with internal and external stakeholders.
Ensure that procedures and guidelines linked to safety and health are met.
Defines the laboratory's strategic planning.
Escalates issues to plant general manager and site quality leader.
Sets short- and long-term priorities for the QC department, aligned with local site.
objectives and the global Quality function.
Develops cost control initiatives.
Qualifications · A Bachelor’s Degree in Pharmacist is required.
A MBA is an asset.
· A minimum of 8 years’ quality experience in a GMP and/or ISO regulated industry is required, of which 4 or more years were held in a leadership position.
Pharmaceutical industry experience is highly preferred.
· Profound knowledge of pharmaceutical regulations/cGMP principles.
· General knowledge of pharmaceutical development & manufacturing.
· Organizational planning and problem-solving experience.
· Strong leadership & development qualities.
· Experience with principles of Process Excellence, Lean manufacturing, etc.
· Strong problem solving and decision making skills.
· Demonstrated ability to work across all levels including Executive management, Planning, Manufacturing and Commercial associates is required.
· Direct interaction and experience in leading teams during Health Authority inspections, internal or third-party inspectors is required.
· Previous experience with budget management and lab capacity is required.
· Capability to manage multiple priorities and unexpected changes.
· Good presentation skills.
· Excellent knowledge of English.
· The position will be based in São Jose dos Campos – Brazil.