Rajesh Chandrasekar

FAQ About Rajesh Chandrasekar

• What is Rajesh Chandrasekar's address?

  Rajesh Chandrasekar is located at
  Mumbai, Maharashtra, India

• What is Rajesh Chandrasekar's job title?

  Rajesh Chandrasekar is a
  1. Handling 15-member team and ensuring that all aspects of the operational business (Complaints / Quality Management) comply with cGMP, Corporate Policies / SOP, Legal and Regulatory requirements in regards with Teva US marketed products. 2. Ensuring team responsible for receipt, classification, processing, and trending of product quality / market / customer complaints and adverse event (AE) reports related to Drugs, Biologics, Medical Devices & Combination Products manufactured / packaged by Teva / Third party sites for Teva US distribution. 3. Review of complaint investigations and handling critical complaints related to Drugs, Biologics, Medical Devices & Combination Products that may need Field Alert report / Biological Product Deviation report (BPDR) / Medical Device Report (MDR) filing. Ensuring all critical product quality complaints are handled in compliance with US FDA regulations and Teva Corporate Policies / SOP practices. 4. Revision of Standard Operating Procedures (SOPs) and Work Instructions (WI) as per process changes and/or align with global corporate policies of Teva. Also making sure the Learning dissemination of revised SOPs and WIs to the team via the Learning Management System (LMS) & Training. 5. QMS – Create, Review of Change Controls, Deviations, CAPAs for US market and monitoring for closure the same. 6. Provide relevant quality input and support to business initiatives, projects, new product introduction / launches for US market. Also review Quality Technical Agreement (QTA) signed with third party vendors in related to roles and responsibilities of quality assurance. 7. Responsible for managing the training and performance of team members in all aspects of complaints management including processes (SOPs / WIs), TrackWise, product knowledge, liaising with manufacturing sites, coordinating the return of complaint samples, use of the phone system and customer service etiquette. 8. Support internal / external / regulatory audits queries / questions related to product quality / market / customer complaints management / QMS. 9. Responsible for quarterly, half-yearly and yearly metrics related to Quality Management System and present the same in Quality Council meetings. 10. Currently working on transition of complaints processing and management to Veeva Vault application. 11. Ensure that coordinated contact is maintained with cross-functional department / team within Teva namely Pharmacovigilance (PV), Medical Affairs Global Security, Legal, Supply Chain, Regulatory, Manufacturing / Packaging (Internal / third party) sites. Teva Pharmaceuticals

• What industry does Rajesh Chandrasekar currently work in?

  Rajesh Chandrasekar currently works in the
  Teva Pharmaceuticals

• What is Rajesh Chandrasekar's area of expertise?

  Rajesh Chandrasekar specializes in
  1. Handling 15-member team and ensuring that all aspects of the operational business (Complaints / Quality Management) comply with cGMP, Corporate Policies / SOP, Legal and Regulatory requirements in regards with Teva US marketed products. 2. Ensuring team responsible for receipt, classification, processing, and trending of product quality / market / customer complaints and adverse event (AE) reports related to Drugs, Biologics, Medical Devices & Combination Products manufactured / packaged by Teva / Third party sites for Teva US distribution. 3. Review of complaint investigations and handling critical complaints related to Drugs, Biologics, Medical Devices & Combination Products that may need Field Alert report / Biological Product Deviation report (BPDR) / Medical Device Report (MDR) filing. Ensuring all critical product quality complaints are handled in compliance with US FDA regulations and Teva Corporate Policies / SOP practices. 4. Revision of Standard Operating Procedures (SOPs) and Work Instructions (WI) as per process changes and/or align with global corporate policies of Teva. Also making sure the Learning dissemination of revised SOPs and WIs to the team via the Learning Management System (LMS) & Training. 5. QMS – Create, Review of Change Controls, Deviations, CAPAs for US market and monitoring for closure the same. 6. Provide relevant quality input and support to business initiatives, projects, new product introduction / launches for US market. Also review Quality Technical Agreement (QTA) signed with third party vendors in related to roles and responsibilities of quality assurance. 7. Responsible for managing the training and performance of team members in all aspects of complaints management including processes (SOPs / WIs), TrackWise, product knowledge, liaising with manufacturing sites, coordinating the return of complaint samples, use of the phone system and customer service etiquette. 8. Support internal / external / regulatory audits queries / questions related to product quality / market / customer complaints management / QMS. 9. Responsible for quarterly, half-yearly and yearly metrics related to Quality Management System and present the same in Quality Council meetings. 10. Currently working on transition of complaints processing and management to Veeva Vault application. 11. Ensure that coordinated contact is maintained with cross-functional department / team within Teva namely Pharmacovigilance (PV), Medical Affairs Global Security, Legal, Supply Chain, Regulatory, Manufacturing / Packaging (Internal / third party) sites.

• Which languages does Rajesh Chandrasekar speak? 

  Rajesh Chandrasekar speaks the following languages:
  No languages available.

• Which industries has Rajesh Chandrasekar previously worked in?   

  Rajesh Chandrasekar has prior experience in the following industries:
  Abbott , Teva Pharmaceuticals , Wns Global Services , Caliber Point Business Solutions , Anbu Medicals

• What is Rajesh Chandrasekar’s work experience?  

  Rajesh Chandrasekar has the following professional experience:
  Teva Pharmaceuticals , Abbott , Teva Pharmaceuticals , Wns Global Services , Caliber Point Business Solutions , Anbu Medicals , Teva Pharmaceutical .

• How can I find Rajesh Chandrasekar on LinkedIn?  

  You can view Rajesh Chandrasekar’s
  LinkedIn profile at LinkedIn URL.

• What are Rajesh Chandrasekar’s work email addresses?  

  Rajesh Chandrasekar’s work email addresses are
  [email protected] .

• What company does Rajesh Chandrasekar work for?  

  Rajesh Chandrasekar works at
  Teva Pharmaceuticals