6 Ema Guidelines Jobs

We are currently seeking a Consumables Engineer for the design of single-use products. ETO service (Engineering to Order) allows our customers to benefit from Sartorius's consumable products perfectly adapted to their bioprocess need through a detailed customization. Work With Us - Your Responsibilities Manage ETO projects in an international environment from definition to final approval Coordinate all activities for the project and create the final design and pricing Define specifications in cooperation with other departments like product development, quality, procurement, MSAT,sales and marketing for more complex projects Making technical and feasibility analyzes of projects Design new cus...

Role Overview: You will be working as an Executive - QC in the Small Molecule Bioanalytical Research Laboratory at Syngene International Ltd. in Bangalore, India. Your main responsibility will be to review data for BA/BE studies in the laboratory, including checking method development, validation, and sample analysis data. You will report to the Head / Group Leader of the Small Molecule Bioanalytical Laboratory. Key Responsibilities: - Perform data checks (QC) for method development, validation, and study sample analysis. - Review STPs, Protocols, validation, and bioanalytical reports. - Ensure necessary documents and records are updated and ready for audits (Sponsor / Regulatory). - Handle ...

You are invited to join ARDEM Data Services Private Limited as a Medical Data Entry professional for patient records with a minimum of 1 year of experience in medical data annotation and document review. The ideal candidate should have a background in medical or pharmaceutical sciences and possess essential skills related to medical data management, regulatory guidelines (FDA, EMA, ICH, GCP), and patient report handling. This role requires prior experience working night shifts and is a permanent work-from-home position. Key Responsibilities - Review and annotate medical documents and patient records accurately. - Apply knowledge of FDA, EMA, ICH, and GCP guidelines to data management tasks. ...

As a Statistical Modeller - Clinical, you will be responsible for utilizing your expertise in clinical trials and clinical data monitoring to develop and implement statistical models. Your role will involve working with Bayesian and Frequentist models, as well as handling EDC, CTMS, ePro, and eCOA systems. You will also be involved in RBQM, signal detection, KRI analysis, and outlier detection. In this position, a strong understanding of GCP ICH E6/8 and EMA Guidelines is essential. Proficiency in statistical software such as SAS, R, JMP Clinical, and Python will be required for data analysis and modelling. Experience with visualization tools like Tableau and Power BI will also be beneficial...

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, I...

The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findin...