QA Manager

Propósito

Ensure the correct application of GMP standards—Good Manufacturing Practices and GLP Good Laboratory Practices in Quality Control—in the company. Manage the quality activities, ensuring compliance with current regulations regarding quality, productivity, training, and team performance.

Principais responsabilidades

• Manage the Quality System, including recall processes, market complaints, returns, deviations, OOS, change control, stability studies, annual product reviews, periodic equipment reviews, equipment qualification, process and cleaning validation, supplier qualification, and self-inspections.
• Oversee risk analysis related to Good Manufacturing Practices (GMP).
• Ensure plant activities meet data integrity requirements.
• Approve quality management procedures applying GMP standards.
• Implement and review processes for quality improvement as needed.
• Monitor the quality of suppliers, distributors, third parties, service providers, and carriers.
• Approve validation documents for manufacturing processes, area cleaning, transport, and analytical methodologies.
• Evaluate technical documentation and authorize product release to the market in case of quality deviations.
• Approve stability protocols and reports.
• Release products for the local and European markets or designate a delegate for this function.
• Provide regulatory support across company departments.
• Manage the Quality Assurance department budget and cost reduction projects.
• Represent the company in regulatory/client inspections and assess sector/document compliance for inspection receipt.
• Motivate and train the team, ensuring flexibility and coverage of activities, including contingencies.
• Manage laboratory team activities to ensure the quality and accuracy of analyses, meeting production planning needs, raw material receipt, packaging material, stability, and validations.
• Ensure correct execution of analyses according to specifications, methodologies, and analytical procedures.
• Investigate and resolve analytical deviations, identifying root causes and corrective actions.
• Develop analytical validations and new methodologies in laboratory routines.
• Ensure proper operation of laboratory equipment through preventive maintenance/calibrations, corrective actions, and requalifications.
• Manage and control quality control investments and expenses.
• Establish an interface between company departments.
• Review documents for regulatory/client inspections and assess industry/document compliance for inspection receipt.
• Set goals and promote subordinate development.
• Implement, maintain, and continuously improve the local Pharmacovigilance Quality System according to regulatory requirements and company quality standards.
• Participate in audits and inspections focused on Pharmacovigilance.
• Support the company in CMO activities, new business, and launches, focusing on Quality impact.

Experiência requerida

Complete Graduate Course in Pharmacy

Fluent English

Quality Assurance, Validations and Qualifications