Quality Assurance/Regulatory Affair - Medical Device / Pharma

Job Description:

• Experience to prepare and review the documentation required for the ISO 9001:2015, EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745, IMDR 2017.
• Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s, Change Control, Deviation, CAPA, Incident, and Customer complaint, Management Review Meeting, pdate Harmonized Standards, Internal Quality Audits, Audit calendar, Audit plan, List of Quality Records, Distribution of documents, PMS and PMCF.
• Preparing and reviewing the Technical Master File (TMF) and Design File for CE Submission accordance with regulatory guidelines.
• Exposure of various countries regulatory such as a African Countires, Latin America, Europe, Maintain compliance with the ROW market. and etc.
• Reviewed the Calibration and Process Validation activity; authorize to maintain DQ, IQ, OQ and PQ of Various instruments.
• Preparing Annual product review report.
• Prepare checklist for the warehouse and vendor audit as per the ISO 13485 standard.
• Submission of license variations and renewals within strict deadlines;
• Prepare the specifications of testing of raw material, In-process Material, Packing Material and Finished Products.
• Monitor and trend key quality objectives of all departments.
• Maintenance of IQA documents with its report and evidence.
• Knowledge and prepare about MRM (Management Review Meeting)
• Maintaining External Audit Documents and compiling its evidence.
• Reviewing and maintaining Artwork, Pack insert and labels.
• Maintain and update Post marketing surveillance reports. Knowledge about
• Coordinate with R&D and manufacturing to develop validation protocol for production process and generating the final report.
• Review all data prior to submission to regulatory agencies, focusing on CE regulatory submissions.
• Support team leader to respond to queries of regulatory authorities and external audits.