Quality Control Manager

Há 7 horas

Vargem Grande Paulista, Brasil Quality Compliance Tempo inteiro

Quality Control Manager

Mission of the Position:
Ensure the efficiency and excellence of laboratory operations by leading multidisciplinary teams focused on the company’s strategic objectives. Promote people management and the implementation of optimized strategies for laboratory routines, ensuring compliance with regulations and quality standards.

Main Responsibilities and Challenges:

  • Manage and oversee all activities related to quality control, including laboratory analyses and process monitoring.
  • Lead the quality control team, guiding daily, weekly, and monthly activities to meet department goals.
  • Ensure compliance with Good Laboratory Practices (GLP) and Standard Operating Procedures (SOPs).
  • Prepare, review, and approve change controls related to the Quality Control department.
  • Analyze and review specifications and testing methods to ensure the accuracy and reliability of results.
  • Prepare and review responses to regulatory inquiries, ensuring alignment with the regulations of competent authorities.
  • Develop and update specifications, test procedures, SOPs, GTPs, and protocols as applicable.
  • Support internal and external audits, as well as implement corrective and preventive actions (CAPA) based on these evaluations.
  • Lead and supervise investigations into quality control nonconformities, ensuring root causes are identified and resolved.
  • Review and approve all documents generated from laboratory activities, ensuring adherence to quality standards.
  • Initiate, review, and close corrective and preventive actions (CA&PA) within the laboratory.

Required Knowledge and Skills:

  • Solid experience in laboratory quality control routines for finished pharmaceutical products.
  • In-depth knowledge of analytical method validation, dissolution profiling, method transfer, and the implementation of certifications such as ISO 17025.
  • Familiarity with RDC 166 and Good Laboratory Practice guidelines.
  • Experience with laboratory software such as Empower, Labsolution, and OMNIS.
  • Strong team management skills, with experience in leading and developing teams.
  • Knowledge of quality management systems, internal auditing, and comprehensive quality control.

Required Education:

  • Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or related fields.
  • Postgraduate degree or specialization in the pharmaceutical field and people management will be a plus.

Work Location:
Vargem Grande Paulista

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