Nirnai Chettri

Experienced Pharmaceutical Professional with an extensive background in cGMP compliance, Quality Assurance. Detail oriented with strong understanding of industry standards and regulations compliance. Responsible for all phases of Quality Assurance for manufacturing and packaging operations.

Honest individual with exceptional background spent in Pharmaceutical Industry. Engaging demeanor to work in demanding environments. Over 7 years in quality assurance, testing and process improvement. Intend to pursue a leading corporate and find a challenging position as an Industrial Pharmacist where to put in efforts and skills for the organization and the people.

• BMR / BPR simplification with respect to quality
• Batch release and approval of COA through LIMS and SAP system.
• Ensure through effective planning: Process Validation are performed according to project timelines, and also to ensure adequate resources available to support the key projects.
• Handling of Validation protocols and reports related to Hold Time, Cleaning Validation, and Process Validation, Packing Validation.
• Usage of Trackwise to ensure all the Change Control, CAPA are closed within the given timeline.
• Review and simplification of BMR/BPR, log books.
• Use of Electronic Data Management System.
• Performing B.U, CU for Process Design ,Process Performance Qualification batches.
• Perform Blend Uniformity and Content Uniformity for Continued Process Verification.
• Sampling for Packed Finished and validation Batches in manufacturing and packing.
• Audit Trials, Preparation of BRC and release of Batch through SAP.
• Usage Decision for BMR/BPR in SAP system.
• Identify and compliance of Observation.
• Process Validation , Cleaning Validation, Packing Validation, Hopper Depletion studies, Hold Time Studies.
• Performing Challenge Test .
• Line clearance, Performing IPQA related through data logger, Pharmatron in Manufacturing and Packing area
• Issuance of BMR/BPR through SAP
• Improvement in Right First Time performance
• Issuance and archiving of the Validation protocols and report.
• Preparation and review of Validation Protocol and Summary Report for Validation Batches.
• Batch release and approval of COA through LIMS and SAP system
• Implement effective CAPA to reduce the number of quality incidences.

• AICTE sponsored workshop on Preclinical Research held at Acharya and B.M.Reddy college of pharmacy.
• Attended Pharma Industrial Orientation course (under the aegis of Karnataka Pharmaceutical Trust Regd.) from 12th April 2014 to 20th May 2014.
• Certification of participation in P.A.C.E organised by Sunpharmaceuticals ltd.
• Certification of participation in SUN FEST organised by Sunpharmaceuticals. ltd.

• Working in shop floor presence, pre-operational inspection and in-process check that regularly appraise the effectiveness, consistency, and applicability of QA system.
• Provide online supervision of each batch dispensing/manufacturing/packaging operations.
• Ensure Dispensed raw materials or packaging materials have been verified for identity, quantity before using any of them in the manufacturing processes. All rooms, main equipment and containers are correctly identified.
• Preoperational checks have been performed according to batch record and relevant SOP if applicable.
• Continuous monitoring of validation batches along with the manufacturing department .
• Ensuring timely sampling of batches and submitting it to the Q.C. dept. for analysis .
• Help in identifying Deviations, non-conformances, or other undesirable situations that do not reoccur and are
  permanently corrected.
• Handling Observations and incidents during routine production, support in Root Cause
  Analysis RCA with the required time frames as per QMS with responsible area owner
  and agree / follow up its corrective and preventive action.

As a nature lover I am very enthusiastic about aquascaping .

I like ready motivational books and reading articles .

I like music and have performed in various cultural fest and music competition and also participated in Brass Band Competition during Independence Day.

As a nature lover i am very enthusiastic about aquascaping.

I love reading motivational books ,articles ,facts.

I like playing keyboards , and have participated in Cultural events and also in Brass Band Display in Independence Day.