Birendra Kumar Email & Phone Number

Karnataka, India

Quality control setup

Bangalore

Ahmedabad, Gujarat, India

• Support to Regulatory for compliance documents as per regulatory needs for data submission.• Preparation of compliance documents for test licence (DSIR), DCGI and successfully submitted BIIP Proposal.• Coordination with regulatory for smooth transfer to improve current quality programs. Support cGMP and testing operation.• Preparation of Site Master File, Qualification documents, Log sheet, check list and support to Quality Assurance activity.• Setting up entire Laboratory for Analytical Development & Quality Control.• Development for Analytical method for Plasma derived product (Human Albumin, IVIG, Factor VIII, IX, PCC and Fibrinogen) as per IP, EP and USP• Support to preparation of Lay out design for Quality Control for Pilot and Commercial Project.• Costing and budgeting for analytical laboratory activity for Plasma derived product.• Selection of Vendor, procurement of Equipments and arrangement of all required items as Consumables, reagents procurement for analytical activity.• Managing & performing Analytical work along with supervised analytical team.

Hyderabad

• Analytical Developement for Plasma derived product (Human Albumin, IVIG Factor-VIII &IX),Quality Control activity & its method validation, stability study protocol and its related documentation.• Selection of Vendor, procurement of Equipments and arrangement of all required items as Consumables, reagents procurement for analytical activity.

Mumbai

- Preaparation and review of STP, SOP, Validation protocol related to Plama derived products.- Preparation of PV protocol for Qualification of Instruments.- Performing finished product related Biochemical and Microbiological testing for plasma derived product as Albumin, IVIG, Factor VIII, Thrombin and its method validation, documentation (STP, SOP, COA etc) in Quality Control.