Quality Assurance Engineer

We are seeking a highly motivated and detail-oriented Quality Assurance (QA) Engineer to join our dynamic team. In this role, you will be instrumental in ensuring the highest quality level of the company processes and products, collaborating in the review and auditing of cGMP documents, coordination of corrective and preventative actions as well as deviations and investigations. In addition, the QA Engineer will be handling quality activities such as collaborating with internal and external audits, root cause analysis, trending of quality systems, and CAPA effectiveness.

Responsibilities

• Support the review and auditing of cGMP documents, including manufacturing, laboratory, and facility records.
• Define internal audit plan for the year.
• Lead internal audits for the company according to the established plan.
• Report to management on internal audit findings.
• Perform follow-up to corrective actions derived from internal audits and report status to management.
• Provide input related to internal audits, change requests, non-conformance reports, planned deviations, OOS investigations, CAPA, etc., for Annual Product Reviews.
• Support root cause evaluation as part of non-conformances and writing the respective investigations.
• Support the coordination of the CAPA Program, including its effectiveness evaluation.
• Support in the appropriate closure of investigations and deviations.
• Maintain corrective and preventative action database, ensuring follow-up and proper and timely closures of CAPAs.
• Support in the coordination of Quality Review Board Meeting as well as Management Review Meeting.
• Support in the performance of trending of quality systems, via evaluation of statistical data.
• Support the continuous improvement program.
• Attend training scheduled for every new or revised SOP related to the department's function.
• Assure accomplishment of the training program.
• Provide excellent service and ensure customer satisfaction, eliminating complaints from internal and external customers.
• Comply with any other function assigned by management.

Qualifications

• Bachelor of Science in Engineering (i.e. Chemical, Industrial, or related field)
• Minimum one year of experience in the pharmaceutical industry in quality activities such as internal audits, external audits, corrective and preventative actions, handling of deviations and investigations, root cause analysis, trending of quality systems, and CAPA effectiveness.
• Excellent verbal and written communication skills.
• Outstanding computer, documentation, and administrative skills.
• Understanding of 21 CFR Parts 210, 211, and 820.
• Understanding of cGMP practices and regulations.

Join us if you’re passionate about joining an organization that is dedicated to enhancing patient care by ensuring that essential medicines are accessible, reliable, and manufactured to the highest standards! We offer an energetic environment where your skills will directly impact product success while supporting your growth as a QA professional.