Job Description

Management of Quality personnel within the Quality department. The Quality department is responsible for the following functions: Regulatory Affairs, Quality Engineering, Quality Assurance, Final Batch Release and Incoming inspection, Documentation Control, Validation and Production Line Clearance. \xef\x82\xb7 Keep up to date of current Quality Standards and Regulations impacting the IVD industry. \xef\x82\xb7 Control of the Quality Manual including preparation, revision and execution. \xef\x82\xb7 Responsible for organising Management Review and compiling and reporting on the performance of the quality system. \xef\x82\xb7 Ensuring that all customer specific quality requirements are compiled with following contract review. \xef\x82\xb7 Management of the product review and release system and signature on Certificates of Conformity. \xef\x82\xb7 Management of Change Control and Document Control Systems. \xef\x82\xb7 Issuing, control and filing of all batch related documentation. \xef\x82\xb7 Responsible for final sign-off on all product labels, package inserts and Marketing Material. \xef\x82\xb7 The organisation of product and facility inspection, preparation of procedures and instructions including certification assessment and surveillance audits, FDA inspections, other regulatory inspections and supplier audits. \xef\x82\xb7 Ensuring that validations are performed on equipment, processes and software used in manufacturing and testing of product. Job Type: Full-time Salary: Up to 595,601.95 per year Speak with the employer
+91 9000320000