Job Description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Executive - Quality Assurance
Company:  B. BRAUN MEDICAL (INDIA)
Job Posting Location:  IN-Chengalpattu
Functional Area:  Quality
Working Model:  Onsite
Requisition ID:  4599
  • The purpose / responsible of this position is to support and maintain all documentations requirement of the plan with respect to QMS,IMS,ISO,FDA, regulatory requirement as per the documented procedure
  • Ensure that all key processes in the plant comply with ISO 13485 : 2016 & EN ISO 13485 : 2016 and other GMP requirements
  • Initiate and play key role in customer feedback system
  • Monitor all CAPA processes closely and generate report on weekly basis to make sure the CAPA activities are completed within the stipulated timeline
  • Support continuous compliance to local and corporate documentation requirement with respects to Pharmacovigilance, ISO, CE, India FDA, etc
  • Support the documentation records and maintain its upkeep for the duration of the project and assist in its timely retrieval
  • Safe retention and quick retrieval of all QMS and regulatory records as defined in the organization procedure for the activity
  • Perform and support all validation activities as per validation master plan and main records
  • Responsible to support implementing Occupational Health and Safety (OHS) management systems, processes and procedures that improves the Occupational Health and Safety of the employees and other interested parties in according to ISO 45001
  • Responsible to support implementation of Environment management systems, processes and procedures in accordance with ISO 14001
  • Responsible for calibration of tools & measuring devices at internal as well as external source
  • To support in review & updation activities of all ISO, CE, India FDA, validation, regulatory & project related documentation requirement
  • To ensure that change and the current revision status of the documents are identified and relevant version of applicable documents are available at the point of use
  • To ensure that documents remain legible and readily identifiable for a period of time as defined by the procedure
  • Prevent the unintended use of obsolete documents and to apply suitable identification to them for the purpose
  • To ensure proper distribution of the controlled documents and their irretrievability
  • To ensure proper calibration and distribution of the monitoring and measuring devices
  • Make optimal utilization of resources within the given environment and work
  • The position should be able to support & co-ordinate all documentation efforts
  • The position should be well versed in MS office, Adobe Reader / edition etc
  • The position should have good communication & inter-personnel skills to interact with various functions in order to co-ordinate the activities
  • The position should have the skills on learning & applying , customer orientation and be able to work in teams
Apply now