BIRANCHI NARAYAN KAR

Meticulous Quality Assurance Professional with 7.0 + years of experience, Accomplished and Energetic Worker with a solid history of achievement in Quality assurance, Motivated Leader with strong organizational and Prioritization abilities, Area of expertise include attention to details, integrity and improving work flow.

• To ensure cGMP compliance at all the levels of manufacturing and packing activity.
• To ensure that the standard operating procedures are followed in shop floor activity.
• To ensure that environmental condition is monitored in respective areas of the operation as per standard operating procedure.
• To ensure that batch manufacturing and packing is carried out as per the instruction in the batch Manufacturing records and batch packing records.
• To grant line clearance at different stage of manufacturing and packing.
• Verification of raw material/packing material during dispensing stage in absence of the dispensing QA persons.
• To ensure online completion of batch manufacturing record and batch packing record.
• Review of audit trail of equipment for critical and non-critical with user management policy.

o Perform verification and calibration of IPQC instrument such as, SMART TEST 50, BALANCE, DISINTEGRATION TEST APPARATUS, FRIABILITY TEST APPARATUS, and TORQUE TESTER. SOTEX HARDNESS TESTER, KARL FISCHER TITRATOR,

o Collection of HOLD TIME STUDY SAMPLE in different stage of manufacturing.

• To ensure the stage wise yields are within the specification mentioned in batch manufacturing record and batch packing records.
• To ensure the collection of process validation samples as per the protocol.
• To ensure that cleanliness and sanitation of the manufacturing area.
• To collects in process, intermediate and finished samples of the product being manufactured.
• Collection cleaning validation sample as per protocol.
• Collection of control sample/ stability samples.
• Preparation and review of Annual product review.
• Initiation of deviation, verification and approval of immediate action required.
• To ensure the proper status libeling to provide easy traceability and identification of material.
• Knowledge of working on training management of all employee.
• Preparation of sop and, uses of D2 Application.

o  To review audit trails of Type II PLC in manufacturing area like Enclony, Sensum, Spine FIBO (Automated Visual Inspection and Bottle Filling Machine), TIS (Tablet Inspection Machine), Fette Compression Machine, Cadmach, RMG, Five Head Powder Filling Machine and Air Jet Bottle Cleaning Machine.

o  To review Quarterly audit trail of all equipment’s in production.

o  To be part investigations and identifying RCA (Root Cause Analysis) in deviations, out of specifications

• USFDA
• Lachman Consulting Services
• MHRA
• 5 Ws Consulting
• WHO
• TGA

· SMART TEST 50

· BALANCE

· DISINTEGRATION TEST APPARATUS

· FRIABILITY TEST APPARATUS

· TORQUE TESTER

· SOTEX HARDNESS TESTER

· KARL FISCHER TITRATOR

·  Friendly with B.M.R, and other documentation.

·  Qualification of equipment’s URS, IQ, OQ, PQ.

·  SIP validation.

·  Change control initiation.

·  CAPA implementation.

·  Risk assessment preparation.

·  Preparation, review, and Unit operation of SOP.

· System Application of Product in Data Processing: SAP

· Laboratory Information Management System LIMS 3.4.0 E

· Incident Management System: IMS

· CPP, CQA report preparation: Minitab

· Software eLogbook: Logbook entry

· Applications: Microsoft excels, Microsoft word, Microsoft ppt

·  SOP preparation: Documentum (D2

E-Mail Address: Biranchikar8@gmail.com

Father’s Name: Sh. Subash Chandra Kar

Mother’s Name: Smt. Arati Kar

Date of Birth: 03th March, 1995