Batch Record Reviewer
📋 Role Overview & Responsibilities
Position background As a Batch Record Reviewer, you will be responsible for meticulously reviewing and analyzing batch records to ensure compliance with regulatory requirements and internal quality standards. You will play a vital role in maintaining the integrity of our manufacturing processes and ensuring the safety and efficacy of our products.
We expect that you have a positive mind-set, able to assess the possibilities to produce more efficient and take action on improvement ideas to do so. In this position you will report to the Director Quality.
Your responsibilities includeReview batch records and associated documentation to ensure accuracy, completeness, and compliance with regulatory requirements.Identify and investigate any discrepancies or deviations in batch records, collaborating with cross-functional teams to resolve issues promptly.Document findings and communicate any quality-related concerns to relevant stakeholders.Participate in internal audits and regulatory inspections as needed, providing support and guidance on batch record review processes.Contribute to continuous improvement initiatives aimed at enhancing the efficiency and effectiveness of batch record review processes.
Your background, qualification, and skillsBachelor's degree in a scientific or technical field preferred.Previous experience in pharmaceutical manufacturing or quality assurance preferred.Strong attention to detail and ability to analyze complex data accurately.Excellent organizational and time management skills.Knowledge of regulatory requirements and guidelines (e.g., FDA, EMA) pertaining to batch record review.Effective communication skills and ability to collaborate with cross-functional teams.
Our offer We will help you become successful in your new job with a customized development plan. At Tjoapack, we work hard, encourage innovative ideas, and give freedom to work independently.
Place within the organization Tjoapack is a global contract packaging organization specializing in pharmaceutical packaging and supply chain management. With over 30 years of experience, we operate in the Netherlands and the United States. Our focus is on making the pharmaceutical supply chain safer and more reliable for customers and patients worldwide. We emphasize continuous improvement, flexibility in packaging solutions, and adherence to market regulations.
If you are passionate about quality and compliance in pharmaceutical manufacturing and possess the necessary skills and qualifications, we invite you to apply for the Batch Record Reviewer position at Tjoapack. Join us in our mission to deliver high-quality medications that improve the lives of patients around the world.
Your application, including a letter of motivation, should be in English and addressed to Samira Houdane, Corporate Recruiter. Apply now using the provided button.
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This position is located in Clinton, TN with potential relocation and sponsorship assistance depending on candidate qualifications.
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