Pharmaceutical Quality Assurance Specialist
1 semana atrás
Our company is seeking a highly motivated and experienced Quality Assurance Specialist to join our team. This is a full-time, permanent position with opportunities for growth and development within our organization.
Key Responsibilities:- Develop and execute commissioning, qualification, and validation protocols for new and existing equipment and processes.
- Conduct risk assessments and gap analyses to identify areas for improvement in compliance and quality.
- Perform equipment and process qualifications, including installation, operational, and performance qualifications.
- Review and approve validation documentation, including protocols, reports, and deviations.
- Collaborate with cross-functional teams, including engineering, manufacturing, and quality, to ensure compliance with regulatory requirements and organizational standards.
- Troubleshoot equipment and process issues and provide technical support to resolve them.
- Participate in audits and inspections, both internal and external, and assist with implementing corrective and preventative actions.
- Keep up-to-date with industry regulations and guidelines related to commissioning, qualification, and validation.
- Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related field.
- Fluent in English and Portuguese.
- Minimum of 3 years experience in commissioning, qualification, and validation in the pharmaceutical industry.
- Strong knowledge of FDA and cGMP regulations.
- Experience with equipment and process validation, including IQ/OQ/PQ, cleaning validation, and process validation.
- Excellent problem-solving and analytical skills.
- Strong attention to detail and ability to work independently.
- Excellent communication and interpersonal skills.
- Ability to prioritize and manage multiple projects simultaneously.
We offer a competitive salary, along with opportunities for professional growth and development. If you are a self-motivated, detail-oriented individual passionate about ensuring quality and compliance in the pharmaceutical industry, we encourage you to apply for this exciting opportunity.
Benefits:- Competitive salary
- Opportunities for professional growth and development
Join us and make a difference in the lives of patients worldwide.
Additional Information:- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Business Development and Sales
- Industries: Pharmaceutical Manufacturing
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