Assistant Manager- QA/RA

0 years

0 Lacs

Posted:4 months ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • Support the regulatory documents to external customer
  • Assist in gap assessment with respect to compliance of USP, ISO and GMP regulations.
  • Preparation and Submission of Application in MD CDSCO Portal.
  • Review and respond to all the requirements of CDSCO and State FDA.
  • Preparation and submission of documents for registration in different countries
  • Participation and arrangement of internal and external audit as per all medical device’s standards.
  • Co-ordinate with QA /production /R&D/Sales and marketing department for documents for documents for regulatory submission
  • To prepare the application regarding the following license —

-Free sale Certificate

-Import License

-Market standing Certificate

-Non -Conviction Certificate

-Wholesale Certificate

-Free Sale Certificate

-Manufacturing license or as Organization requirement.

  • To update regulatory status for all the application on timely basis
  • To prepare and maintain backup in soft copy for all application and in hard copy for important application
  • To maintain and update original license /Certificate file
  • To respond to the queries of regulatory authorities
  • To review instruction for use, brochure, labels etc. by coordinating with various department i.e., production, Quality Assurance, Quality Control.
  • To attend the meeting for various regulatory affairs related work on timely basis
  • Update and Support technical file for all products.
  • To communicate and intimate the notified body.
  • To keep track for various letters (Approval Letter/Clarification letter)
  • Gap analysis between MDD vs EU MDR2017/745 and implementation of new procedure.
  • Technical file Support as per EU MDR2017/745 and file submission to Regulatory Agencies.


B) Quality Assurance and Quality Control

  • Plans, Coordinates, and directs Quality Assurance program designed to ensures continuous production of products consistent with established standards.
  • Manages overall site Quality Assurance program in compliance with all applicable regulations and policies, including FDA, safety and environmental.
  • Ensure all facility associates are educated in the regulatory requirements.
  • Assures that QA/QC labs are appropriately staffed and run in a safe, clean and environmentally sound manner.
  • Manages overall effective implement Quality system to ensure that the facility remains continually certified to ISO and the quality System is regularly audited/reviewed and that changes needed are implemented in a timely fashion.
  • Ensure complaints investigations and closure from site on time.
  • Ensures resolution of daily quality control issues, inter and intra departmentally.
  • Ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies and instrumentation.
  • Lead during the audit and support during the external audit.
  • Reviewing and approving quality Records (e.g. non-conformances, CAPA) related to laboratory events and sites.

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