Laboratory Quality Assurance
3 weeks ago
- You are a qualified professional with 10-15 years of experience in Quality Assurance (Laboratory) looking for an opportunity to work with Medivant Healthcare, a renowned pharmaceutical company based in Phoenix, Arizona. As a key member of the Quality Assurance department, you will be responsible for ensuring the quality and compliance of pharmaceutical products produced by the company.Your primary responsibilities will include reviewing and verifying analytical data from chemical and microbiological analysis, ensuring data integrity and compliance with cGMP and regulatory standards. You will also be responsible for approving Certificates of Analysis (CoA) for final product release.In addition, you will conduct and review investigations related to laboratory incidents, out-of-specification (OOS), and out-of-trend (OOT) results. You will identify root causes and recommend corrective and preventive actions (CAPAs) to ensure the quality and safety of the products.You will be required to review and analyze quarterly trends for environmental monitoring, personnel monitoring, and OOS results. Collaborating with microbiology and analytical teams, you will implement corrective measures based on trend analysis to maintain a sterile manufacturing environment.Method transfer and validation activities will also fall under your purview. You will oversee method transfer activities between manufacturing sites or contract laboratories, ensuring that analytical methods are validated and suitable for their intended use. Additionally, you will review and approve method validation reports.Your role will also involve overseeing environmental and personnel monitoring data to ensure manufacturing environments" sterility. You will implement corrective measures when trends indicate potential contamination risks, thus upholding high-quality standards.You will play a crucial role in preparing the laboratory for internal and external audits, including those conducted by US FDA, state FDA, and customer audits. By conducting pre-audit checks and addressing audit observations, you will ensure compliance and timely closure of identified gaps.To excel in this role, you must possess in-depth knowledge of Quality Control in sterile injectable manufacturing processes, experience in laboratory oversight for chemical and microbiology, strong analytical and problem-solving skills, effective communication and documentation skills, and the ability to manage cross-functional teams and prioritize tasks. Proficiency in QMS tools and software will be an added advantage.You should hold a Bachelors/Masters degree in Pharmacy, Science, Biotechnology, Microbiology, or a related field to qualify for this position at Medivant Healthcare. With your expertise and dedication, you will contribute significantly to maintaining high-quality standards and regulatory compliance in pharmaceutical manufacturing.,
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- Laboratory Quality Assurance (QA) Specialist Sterile Injectables
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