Product Compliance Specialist

2 days ago

Jamnagar, India beBeeQuality Full time

Quality Assurance Officer Job DescriptionWe are seeking a Quality Assurance Officer to join our organization. The successful candidate will be responsible for assessing and pre-qualifying manufacturers and products.The role involves:Performing desktop evaluations of plants as applicable;Verifying ISO and other certificates for authenticity with the certificate issuing body;Visiting manufacturers for document or cause audits as needed;Collecting and assessing documents for product approval, including product questionnaires, specifications, release criteria, and stability studies;Reviewing and approving product documentation in SharePoint;Verifying CE and other certificates for authenticity with the certificate issuing body;Engaging in necessary discussions with manufacturers to resolve product queries;Preparing assessments for product approval and datasheets;Assisting in reviewing pharmaceuticals and medical devices for layout approval and review;Evaluating temperature files from shipments reaching customers;Creating item codes and plant codes in AX;Handling QD mailboxes, ECM requests, and assisting with quality support functions;Implementing quality management systems and complying with global and site-specific procedures;Supporting corporate QA in defining, revising, and implementing QMS and SOPs;Evaluating temperature files of warehouses and concluding with justifications or risk assessments;Implementing various projects involving quality functions;Providing segment-specific solutions for quality-related issues.Required Skills and QualificationsA Master's/Bachelor's degree/diploma in Pharmacy or Science stream;4-6 years' experience in QA/QC/Production/Regulatory departments of manufacturers, preferably for international markets;Hands-on experience with quality systems, GMP issues, SOPs, stability, QA/QC, and manufacturing processes;Basic understanding of overall quality management systems (QMS) and ability to handle various QMS documents;Knowledge of WHO tech reports, EU GMP, ISO 9001, ISO 13485, and ICH guidelines, and ability to explain and justify audit findings;Excellent communication skills and ERP system/SharePoint proficiency;Well-structured, detail-oriented, and efficient with the ability to follow up and communicate results;Ability to review documents like Certificates of Analysis, Site Master Files, stability studies, and product specifications;Capacity to engage in dialogue with external parties like manufacturers/laboratories to improve products/GMP levels;Proficiency in Microsoft Office package, particularly Word, Excel, and PowerPoint;Adherence to core values and team player personality traits.BenefitsThis role offers opportunities for professional growth and development, working with a dynamic team, and contributing to the success of the organization.OthersIf you are a motivated and experienced Quality Assurance Officer looking for a new challenge, please apply for this exciting opportunity.

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