Pharmaceutical and Medical Device Quality Assurance Specialist

1 week ago


Gandhinagar, India beBeeQuality Full time

Job Title:Pharmaceutical and Medical Device Quality Assurance SpecialistJob DescriptionThis is a pivotal role in ensuring the quality of pharmaceutical and medical device products. Our team focuses on delivering excellence through rigorous assessments, meticulous documentation, and effective communication.The ideal candidate will have a strong background in QA/QC, with experience in assessing and qualifying manufacturers and products. They will be responsible for coordinating documents, executing projects, and performing QA-related tasks.Key ResponsibilitiesConduct thorough desktop evaluations of plants and verify ISO and other certificates for authenticity.Visit manufacturers for document or desktop audits as needed, and ensure compliance with regulatory requirements.Collect and assess product documentation, including questionnaires, specifications, release criteria, and stability studies.Review and approve product documentation, and verify CE and other certificates for authenticity.Prepare assessments for product approval and datasheets, and assist in reviewing pharmaceuticals and medical devices for layout approval and review.RequirementsMaster's or Bachelor's degree in Pharmacy or Science stream.4-6 years' experience in QA/QC/Production/Regulatory departments of manufacturers of finished dosage forms, preferably for international markets.Updated knowledge of WHO technical reports, EU GMP, ISO 9001, ISO 13485, and ICH guidelines.Excellent communication skills and proficiency in ERP systems/SharePoint.Ability to review documents such as Certificate of Analysis, Site Master Files, stability studies, manufacturing processes, and product specifications.CompetencesBasic understanding of overall quality management systems (QMS) and ability to handle QMS documents.Ability to engage in dialogue with external parties to improve products/GMP levels.Proficiency in Microsoft Office package, particularly Word, Excel, and PowerPoint.



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