Product Approval Specialist

4 days ago

vijayawada, India beBeeQuality Full time

Quality Assurance OfficerThe Role:We are seeking a Quality Assurance Officer to join our team. This is a challenging role that requires excellent communication skills, a high level of analytical ability and strong organizational skills.Responsibilities: Perform desktop evaluations of plants as applicable. Verify ISO and other certificates for authenticity with certificate issuing bodies. Visit manufacturers for document/DESKTOP audit or cause audits on a need basis. Collect and assess documents needed for product approval including but not limited to product questionnaires, product specifications, release criteria and stability studies. Review and approve product documentation in SharePoint. Verify CE and other certificates for authenticity with certificate issuing bodies. Undertake necessary discussions and explanations with manufacturers regarding product queries. Prepare assessments for product approval and product datasheets. Assist in reviewing pharmaceuticals and medical devices with reference to layout approvals and reviews. Evaluate temperature files from shipments reaching customers. Create item codes and plant codes in AX. Handle QD mailboxes, ECM requests and assist with quality defect support functions. Assist in implementing quality management systems and compliance to global and site-specific procedures. Support corporate QA in defining, revising and implementing QMS and standard operating procedures. Evaluate temperature files of warehouses and conclude with proper justification or risk assessment. Assist in implementing various projects where quality functions are involved and required.Requirements: Bachelor's/Master's degree/Diploma in Pharmacy or Science stream. Work experience: 4-6 years' experience from QA/QC/Production/Regulatory departments of manufacturers of finished dosage forms preferably for international markets. Hands-on experience with quality systems and GMP-related issues including SOPs, stability, QA/QC and manufacturing processes.Competencies Required: Basic understanding of overall quality management systems (QMS) and handle various documents of QMS. Updated on WHO tech reports, EU GMP, ISO 9001, ISO 13485 and ICH guidelines and explain and justify audit findings in simple understandable manner. Excellent communication skills, understand and orient towards ERP systems/share point and use it efficiently within own area. Well-structured, detail-oriented, efficient with ability to follow up and communicate results. Ability to review documents such as Certificate of Analysis, Site Master Files, stability studies, manufacturing processes and product specifications relating to a product. Ability to enter dialogue with external parties such as manufacturers/laboratories to facilitate improvement of the product/GMP level. Proficiency in Microsoft Office package, particularly Word, Excel and PowerPoint. Familiarity with core values and being a team player. Self-confident personality knowing right code of conduct.

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