Diksha Rana

Responsible for leading audits as the QA representative.

Responsiblr for Handling QA team.

• Conducted thorough audits of production processes, ensuring compliance with industry standards and regulations.
• Collaborated with cross-functional teams to develop comprehensive quality assurance plans for new product launches.
• Implemented root cause analysis techniques to identify recurring issues and drive corrective actions within the production process.
• Developed training materials and conducted workshops to educate staff on best practices in quality control.
• Reduced customer complaints by closely monitoring product defects and addressing issues promptly.
• Improved overall QA process efficiency by redesigning workflows and introducing new tools.
• Performed root cause analysis to identify and resolve quality issues and defects.
• Conducted risk assessments to identify and mitigate potential quality issues.
• Created and maintained quality management systems to align with industry standards.

Handling of QMS

• (Change control, Deviation, Incidence, OOS etc.)
• To review Artworks as per current guidelines and finalize the dimensions as per change parts/ Layouts
• Handling of Self inspection in plant
• Responsible for all Lab QA activities
• Responsible for Vendor Audit & its documentations
• Responsible for lead in Audits as QA representative
• To co-ordinate with clients for product related queries

• Over all responsible for the QA Activity like:-
• To prepare and review Batch Manufacturing & Packing record
• To prepare and review Master Formula record
• To prepare and review Protocols & Reports of Process Validation as per current guidelines
• Handling of Self inspection in plant
• Handling of QMS
• To Prepare & review Stability summary sheets
• To review Artworks as per current guidelines
• Handling Control Samples

• Over all responsible for the Lab Quality Assurance, QA & QC Activity like
• To prepare and review Standard operating procedures
• To Develop and train subordinates and production associates to achieve desired Quality Levels (Inclusive on cGMP, SOPs and on Job Training
• Responsible for the Induction training of the new joinee
• Responsible for preparation of Job responsibilities, Training Matrix & Training Calendar
• Responsible for issuance of Training related Documents
• Handling of Self inspection in plant
• Handling of Change Control
• Preparation and handling of master lists at site as per procedure
• To prepare and review Site Master File
• To assist Quality Assurance Head to establish lay down and implement Quality system, SOP’s and Documentation as per cGMP
• To assist Quality Assurance Head in Audit Compliance
• Online Data review in Quality control Lab
• Online Checked Entries in Quality control lab
• To Aware Quality Control Analyst Regarding OOS, OOT
• To Aware (QA/QC) regarding ALCOA
• To Review Specification & STPs
• To ensure cGMP compliance
• To Co-ordinate for inter-departmental and Intra-departmental training sessions
• Daily monitoring of quality assurance document activities
• Working in ERP Software for Dispatch of Finished products From QA for QA approval

• Working In Raw Material Section for 2 years approx.
• Working in GLP Section for 1 year approx.
• Handling of QC instruments like (HPLC, GC, Dissolution, Disintegration, friability, Karl-fisher, IR etc.)
• To perform testing of Raw Material (Chemical tests, LOD, S
• Ash etc.)
• Release of Raw Material & Finished Goods
• To prepare final COA of RM, FG, PM
• Calibration of instruments like (Disso, IR, KF, Polari-meter, Melting Point Apparatus, Potentiometer, Weighing-balance) as per SOPs
• Daily monitoring of quality control document activities
• Working in LIMS, EDCS, EQMS and ERP environment
• To perform Water Testing
• To perform all test of QC like Assay, Disso, Identification etc