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, s…
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, s…
Skills: Deviation Analysis, Environmental Monitoring, Water System Validation, Microbiology, Gas Analysis
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, s…
Skills: EHS Program Management, Root Cause Analysis, Risk Assessment, Regulatory Compliance, Incident Investigation
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Full-time
Competitive Compensation, Professional Growth Opportunities, Inclusive Work Environment
Posted 45d ago
~40 hrs/week
Responsibilities
The QA Specialist provides oversight of daily operations to ensure compliance with GMP and internal quality standards. Key duties include reviewing deviations, CAPAs, and batch records, as well as conducting on-site audits and supporting validation activities.
Requirements
Candidates must have at least 5 years of experience in pharmaceutical or biotech QA and be fluent in Spanish. Availability to work weekends and a minimum 6-month commitment are required.
Full job description
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 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.
Related keywords
GMPCAPADeviationChange ControlBatch Record ReviewData IntegrityPharmaceuticalBiopharmaceuticalQuality AssuranceEnvironmental MonitoringValidationRoot Cause AnalysisQC AreasMicrobiological Control
Now part of the Efor Group | Committed To Excellence
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Headquarters
Toronto, Ontario
LinkedIn followers
41,286
PharmEng Technology, now part of Efor Group, leader in Compliance Engineering, is a leading provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
As part of Efor’s global network of 3,000 experts across 12 countries, we are better equipped than ever to deliver innovative and comprehensive solutions tailored to the unique needs of clients worldwide. This integration strengthens our ability to combine global expertise with local proximity, positioning PharmEng as a strategic partner for the industry’s most prominent players.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique challenges.
At PharmEng Technology by Efor, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives, developing customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical, and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).
Offices: 23 Lesmill Road, Suite 410, Toronto, Ontario M3B 3P6, CA · 2475 Northwinds Parkway, Suite 200, Alpharetta, Georgia 30009, US · 2500 Regency Pkwy, Cary, North Carolina 27518, US · 866 Yuhangtang Road, Hangzhou, CN · 116c 2F Quang Trung Street, Haoni City, VN
Now part of the Efor Group | Committed To Excellence
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Headquarters
Toronto, Ontario
LinkedIn followers
41,286
PharmEng Technology, now part of Efor Group, leader in Compliance Engineering, is a leading provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
As part of Efor’s global network of 3,000 experts across 12 countries, we are better equipped than ever to deliver innovative and comprehensive solutions tailored to the unique needs of clients worldwide. This integration strengthens our ability to combine global expertise with local proximity, positioning PharmEng as a strategic partner for the industry’s most prominent players.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique challenges.
At PharmEng Technology by Efor, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives, developing customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical, and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).
Offices: 23 Lesmill Road, Suite 410, Toronto, Ontario M3B 3P6, CA · 2475 Northwinds Parkway, Suite 200, Alpharetta, Georgia 30009, US · 2500 Regency Pkwy, Cary, North Carolina 27518, US · 866 Yuhangtang Road, Hangzhou, CN · 116c 2F Quang Trung Street, Haoni City, VN