Job Description

• Candidate should be aware with ISO 13485, cGMP, GLP, and GDP guidelines and can prepare/manage all quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
• Good knowledge on Quality Assurance of the product from Raw Material to Final Product along with good understanding of entire Quality Management System and procedure.
• Reviewing current accreditation, harmonized standard/regulatory requirement, performing gap analysis and ensuring compliance to current requirements.
• Preparation, Monitor and maintenance of existing processes of production and Quality and respective documentation as per ISO 13485, cGMP, GLP requirements for medical devices.
• Handling and control of documents & records and its distribution.
• Assist in creating and maintaining internal audit schedules and records including tracking CAPA activities as required. Execute and follow-up on internal audit recommendation.
• Assist to QA team for certification audits, customer audits or other inspections.
• Assist to QA team for supplier audits, assist in investigating quality issues and interact with products suppliers regarding these.
• Reviewing Batch Manufacturing Records (BMR), and batch release documents.
• Preparation & updation of all products artwork of labeling, IFU's, brochures, for compliance with applicable regulations and policies & customer requirement.
• Assist to QA team to ensure full compliance & implementation towards the Quality Management System, processes and procedures and alignment.
• Preparation and maintenance of Training schedule on Quality Improvement Programs.
• Preparation of Annual product review reports and rejection trend analysis reports. Evaluation of rejection trend analysis.
• Handling of Deviation Notes and Non-conformities related to all Production activities and Analysis for defects
• Handling of OOS, OOT, planned and un-planned deviations as per standard procedure.
• Preparation and Maintenance of Customer complaints database determine product failure root causes and evaluate risk of failures and assisting the Product development team in Improvement of the product.
• Preparation, Review of Verification (DQ, IQ, OQ and PQ) and Validation protocols and reports for Equipments.
• Establish and maintain instruments calibration procedures and maintenance schedules.
• Monitoring of Cleanroom, and its validation program schedule.
• Establish and maintenance of validation schedules and execute validation program accordingly.
• Handling of change control management and maintain the Change history.
• Can work with ERP or other equivalent data & documents management software.
• Perform all duties assigned by the Head / designee.

Job Types: Full-time, Permanent

Pay: ?400,000.00 - ?500,000.00 per year

Benefits:

• Commuter assistance
• Health insurance
• Paid sick time
• Provident Fund

Education:

• Bachelor's (Preferred)

Experience:

• total work: 4 years (Preferred)

Work Location: In person