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QA Specialist
hace 2 semanas
PharmEng / Efor
is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated Automation Engineer to join our team.
Position:
Quality Assurance Specialist
Experience Required:
Minimum 5 years
Language:
Fluent Spanish
Availability:
Must be available to work occasionally on weekends; minimum 6-month uninterrupted commitment
Overview
We are looking for a highly skilled
QA Specialist
to join our Quality Assurance team. The ideal candidate brings strong GMP knowledge, experience in deviation/CAPA management, batch record review, and QA oversight in a regulated environment.
Key Responsibilities
- Perform QA oversight of daily operations, ensuring compliance with GMP and internal quality standards.
- Review and approve deviations, CAPAs, change controls, and other quality records.
- Support root cause investigations and ensure timely and effective CAPA implementation.
- Conduct batch record review and release processes, ensuring data integrity and regulatory compliance.
- Perform on-site GMP audits, walkthroughs, and quality checks on production and QC areas.
- Support Environmental Monitoring (EM) oversight and ensure adherence to microbiological control strategies.
- Participate in validation activities, such as equipment, utilities, and water system validation, from a QA perspective.
- Ensure compliance with data integrity principles and maintain high-quality documentation.
- Collaborate cross-functionally to promote continuous improvement and quality culture.
Qualifications
- Minimum 5+ years of experience in Quality Assurance (pharma, biotech, or related regulated fields).
- Fluent in Spanish (spoken and written).
- Solid experience with deviation investigations, CAPAs, change control.
- Strong understanding of GMP, data integrity, validation processes, and quality systems.
- Availability to work occasionally on weekends.
- Excellent attention to detail, communication, and problem-solving skills.
Join us:
If you are a dedicated and highly motivated person with a passion for ensuring the highest standards of Quality Assurance in the Pharmaceutical Industry, we encourage you to apply. PharmEng / Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions.
PharmEng/Efor is an equal opportunity employer and welcomes applicants from all backgrounds.
Thank you for your consideration and application We review all resumes and submissions, however, due to the high volume of applications we receive, only approved candidates will be contacted.
