Arun Gupta Email & Phone Number

Hospira Vizag, India

Was part of a greenfield site in providing Quality oversight for set up of manufacture of sterile injectables where had to set up the QA systems and processes. Responsible for setting up and execution of Quality Compliance guidelines and policies on site, Internal audits, Site audits (US-FDA and Indian FDA), Supplier Audits, Complaints, Training, Technical Transfer, Change Control, Documentation and review of Regulatory submission. Involved in recruiting personnel for Quality department. Investigations and problem resolution for Operations. Also as Head of QA IT Systems played major role in implementation of SAP system and GMP assessment of Computerised Laboratory and Manufacturing systems.

Third Party Manufactured Product Quality - Drug Products and Medical Devices, Authorised Person (QP) Batch Release for sale/supply ANZ and Asia, Vendor Audits, Deviation Investigations, Customer Complaint investigations, Change Management, Annual Product Quality Reviews, Product Recalls, Technical Agreements, Review Regulatory Submissions. Liaised with TGA and Medsafe in relation to significant Quality issues for both Drug products and Medical Devices.

Quality Management, Complaince, Technical transfer, Batch disposition Finished product and Starting Material, Vendor Audits, Complaints

Annual Product Reviews, Manufacture investigations, GMP training, Batch disposition, Audits