Niraj Sharma

• Reporting to Operations Director about new achievements, Strengths, Weaknesses and opportunities.
• Developed new anlytical Methods for assay and RS on HPLC.
• Managing and training the team of at least 20 people.
• Performed Qualifications of various Laboratory equipments including microbiology lab and water purification system.
• Did trend analysis of new drug products as per stability data.
• Implemented new Quality Control Standards and procedures to improve efficiency of the laboratory.
• Prepared Standard Operating Procedures, Specifications and Methods of analysis as per comondial or non-compendial procedures.
• Responsible for verifying and initiating any QMS related issue like Chang Controls, Deviations, Incidents, Out of Specifications and Out od Trend Results.
• Responsible for verifying and approving RM, IP, FG and Stability Studies chemical and microbiological analysis results.
• Responsble for maintaining chemical and microbiology inventory and order in a timely manner.
• Developed and analyzed quality control processes and deliverables to determine present standards and establish recommended action plans.
• Collected and analyzed Type material samples to evaluate quality, providing feedback and interpretation to production management or staff.
• Used Software to produce reports regarding daily production quality, nonconformance of products or processes and quality trends.
• Conducted audit inspections and independent checks to verify parts and materials.
• Maximized quality and reduced costs Number% by maintaining QC objectives.
• Updated quality control standards, methods and procedures to meet compliance requirements.
• Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
• Provided observations, took measurements and performed tests at various stages according to quality control plan.
• Orchestrated and led team in executing gauge repeatability and reproducibility studies cataloging all major Type devices on floor.
• Devised specifications for processes.
• Mentored and encouraged employees to strive for excellence while fostering professional growth.
• Managed and archived quality documentation and participated in internal and external quality audits.
• Increased customer satisfaction through adherence to quality standards and customer requirements.
• Improved quality processes for increased efficiency and effectiveness.
• Equipped and organized facility to comply with company strategy for online and offline quality controls.
• Collaborated with contract representatives and oversaw quality control implementations and reporting.
• Inspected inbound and outbound products for compliance with established industry standards, company policies and procedures.
• Rejected defective products and approved correct products.
• Wrote and implemented new rework procedures to standardize processes and streamline workflow.
• Evaluated quality problems and performed assessments to identify and resolve issues.
• Calibrated instruments and scales in production area and quality lab.
• Liaised with HR manager to organize and perform quality standard training for new and existing staff.

• Responsoble for adding and approving analysis results on SAP software.
• Performed online and offline review of HPLC and other Instruments.
• Choking of Hard Data from approved specifications.
• Performed In Process Validations on HPLC.
• Handled various instrumental softwares like Empower 2, Open Lab and EZ chrome Elite.
• Handled various make HPLCs like Waters, Shimadzu and Agilent.
• Completed precise measurements using special tools.
• Inspected quality of products, taking note of functionality, appearance and other specifications.
• Communicated with production team members about quality issues.
• Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
• Evaluated components and final products against quality standards and manufacturing specifications.
• Disposed of unsound and unsafe materials, products and equipment to prevent inappropriate reuse.
• Repaired faults, reassembled products and completed additional tests.
• Used hand tools, instruments, gauges and equipment to complete accurate measurements and noted results for official records.
• Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
• Monitored company inventory to keep stock levels and databases updated.
• Worked within applicable standards, policies and regulatory guidelines to promote safe working environment.
• Used Microsoft Word and other software tools to create documents and other communications.
• Carried out day-to-day duties accurately and efficiently.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Maintained energy and enthusiasm in fast-paced environment.

Performing Analysis of Raw Materials as per Approved Specifications.

Handled various Hardware and Software aspects of all QC equipments and Instruments Like HPLC, UV Spectrometer, FTIR Specttometer, autotitrator, Karl Fischer etc.

Perfomed Data entry on LIMS.

Anlysed Raw materials, Intermediates and FG on HPLC for tests Like Related Substances, Assay and Chromatographic Purity.

Handled agilent HPLC to analyse Routine samples like RM, In Process and FG.

Trained other staff about new procedures and quality standards as per GLP practices.

As a part of Instrumentation HPLC section was just involved in HPLC analysis of APIs at different stages.

Reporting to manager about day to day activities.

Did raw material sampling and chemical analysis of raw material.

Coordinate with warehouse staff to perform sampling of Raw materials.

Affix rejected or approved labels on containers.