Quality Assurance 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 seeking a highly qualified and motivated Quality Assurance Specialist to join our team. The QA Specialist will ensure that all products, processes, and documentation comply with regulatory standards such as FDA, EMA, and GMP. This role is vital to maintaining product safety, efficacy, and quality throughout the manufacturing lifecycle. Responsibilities Monitor and enforce GMP compliance across manufacturing and laboratory operations. Review batch records, SOPs, and validation protocols to ensure accuracy and regulatory alignment. Conduct internal audits and inspections to identify non-conformances and recommend corrective actions. Investigate deviations, CAPAs, and complaints to ensure timely resolution and documentation. Support regulatory submissions and inspections by preparing documentation and participating in audits. Train staff on quality procedures and compliance standards. Maintain and update QA documentation systems including change controls and risk assessments. Qualifications Bachelors degree in Pharmacy, Chemistry, Biology, or related life sciences field. 4+ years of QA experience in a pharmaceutical or biotech environment. Strong knowledge of GMP, ICH Q10, FDA, and EMA regulations. Experience with quality systems, CAPA management, and validation documentation. Skills Exceptional attention to detail and analytical thinking. Strong written and verbal communication skills. Proficiency in QA software and documentation tools. Ability to work independently and in cross-functional teams. Join us If you are a dedicated and highly motivated individual with a passion for ensuring the highest standards of Engineering and Quality 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. #J-18808-Ljbffr
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