Regulatory Affairs Executive

Year    GJ, IN, India

Job Description

To document, prepared the Quality as well as various technical documents & co-ordinate approval from the Authorize Person as per the Policy of the company and in line with MDR& QMS Requirement.. To establish the Quality Management System in the company at all levels System Management as per ISO 13485 Audits & NCR Closing Make Internal Audit function as per the requirement of the Quality Systems To co-ordinate within all functions as far as the Quality System is concern Make document for Management Review meeting. Provide Support Record/Documents to the QA Head about the functioning of the Quality Management Systems in the company during Management Review Meeting. To co-ordinate and Prepared the corrective action against internal /External audit findings To maintain Quality records pertaining to his function. Prepared the required changes in implementing, maintaining and imparting the quality system & get Respective Approval from QA Head. Control sample preservation & monitoring Review of BMR High Light System Related Deviation throughout Company & Report to QA Head. Monitoring Objective of each Functions Records & get approval on monthly bases from authority. Handling Complaint. Issuance of Batch Through BMR/IPQC control Formats Weekly verification of various Department. Monitoring Schedule of all validation, calibration, stability, control sample, observation, Bio burden, Fumigation. Prepared & Monitoring of Process Validation, machine validation etc. Improve awareness among team member for effective IPQC. Co-ordinate for Design Development, Post market surveillance, Risk management analysis, field safety corrective action etc. Being an Active Participant for Continuous Improvement/various Product development activities. Raising Change Note /Suggestion. Maintaining Stock of Printed Documents. Maintain & Monitoring of Monthly QC Report & BMR Status
Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹40,000.00 per month

Benefits:

Leave encashment Paid sick time Paid time off Provident Fund
Work Location: In person

Beware of fraud agents! do not pay money to get a job

MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.


Job Detail

  • Job Id
    JD4207743
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    GJ, IN, India
  • Education
    Not mentioned
  • Experience
    Year