Quality Assurance Specialist

Há 4 dias

Região Geográfica Intermediária de São Paulo, Brasil beBeeQuality Tempo inteiro R$67.000 - R$93.000

We are seeking a highly motivated and experienced Quality Assurance Specialist to join our team.

As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our pharmaceutical manufacturing processes and equipment.

This is a full-time, permanent position with opportunities for growth and development within our company.

Key Responsibilities
  1. Develop and execute protocols for new and existing equipment and processes.
  2. Conduct risk assessments and gap analyses to identify areas for improvement in compliance and quality.
  3. Perform equipment and process qualifications, including installation, operational, and performance qualifications.
  4. Review and approve validation documentation, including protocols, reports, and deviations.
  5. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company standards.
  6. Troubleshoot equipment and process issues and provide technical support to resolve them.
  7. Participate in audits and inspections, both internal and external, and assist with implementing corrective and preventative actions.
Qualifications
  1. Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related field.
  2. Fluent in English and Portuguese.
  3. Minimum of 3 years experience in commissioning, qualification, and validation in the pharmaceutical industry.
  4. Strong knowledge of FDA and cGMP regulations.
  5. Experience with equipment and process validation, including IQ/OQ/PQ, cleaning validation, and process validation.
  6. Excellent problem-solving and analytical skills.
  7. Strong attention to detail and ability to work independently.
  8. Excellent communication and interpersonal skills.
  9. Ability to prioritize and manage multiple projects simultaneously.

This role offers a competitive salary, along with opportunities for professional growth and development.

Additional Information
  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Job function: Business Development and Sales
  • Industries: Pharmaceutical Manufacturing

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