Harshit Kumar Ram

To achieve and surpass professional and personal targets in the organization where I work and to demonstrate my inbuilt to attain the highest level of success by performing to the best of my abilities.

Successful Executive with over [Number] years of demonstrated ability in delivering mission-critical results. Offering outstanding communication and cross-cultural team management skills. Entrepreneurial attitude for optimal profitability. Ambitious team leader adept at creating strategic alliances with organizational leaders and effectively aligning with and supporting key business initiatives.

HARSHIT KUMAR RAM

Mobile No: +91 9844388865

Email id: ramharshitkumar@gmail.com

To

The HR department

Respected sir

• I take this opportunity to introduce myself. I am Harshit Kumar Ram. I obtained my Master of Pharmacy degree from the Roland Institute of Pharmaceutical Sciences, which is connected to Biju Patnaik University in Odisha.
• I am attaching my curriculum vitae for your kind review and consideration as I am currently here. I would be more than happy to work for your prestigious company, where I can put my skills and experience to use in support of both organizational and individual advancement. In the role you offer, I will contribute positively to the best of my abilities.
• I really believe that your company will greatly benefit from my wealth of knowledge in the quality assurance department. Even though my resume is sufficiently thorough, I would prefer to interview in person to discuss my qualifications and the potential fit for your company. Please review my résumé, which is provided. Please do not hesitate to contact me at +919844388865 if you have any queries or would like to arrange an interview. I am looking forward to speaking with you in person shortly. Thank you for taking the time to read this.

                                                                                                                                                                                                               Yours sincerely

                                                                                                                                                                                                               Harshit Kumar Ram

Micro labs Private Limited (Documentation)

• Prepared and maintained comprehensive Batch Manufacturing Records (BMR), Master Formula Records (MFR), Master Packaging Records (MPR), and Batch Packaging Records (BPR) in full compliance with cGMP, GDP, and applicable regulatory standards.
• Finalized BMR documentation based on process validation reports, ensuring accuracy, regulatory compliance, and audit readiness.
• Executed process validation activities, including preparation and review of Process Validation Protocols (PVP) and Process Validation Reports (PVR).
• Coordinated and supported validation batches by monitoring critical process parameters (CPPs) and critical quality attributes (CQAs) to confirm process consistency, robustness, and reproducibility.
• Performed validation data analysis to evaluate batch-to-batch variability and ensure that all results met established acceptance criteria and regulatory expectations.
• Compilation, review and updating Annual Quality Product Review (APQRs).
• Preparation and Review of SOPs for Quality Assurance and other department SOP’s.

Bioplus Private Limited (IPQA In charge/Documentation)

• Review of BMRs & BPRs Trending the critical quality parameter and yields and recommending the necessary actions.
• Handling deviations, change controls and document management.
• Compilation, review and updating Annual Quality Product Review (APQRs).
• Preparation of self-inspection schedule follow-up with auditors and auditees for closure of self-inspection.
• Monitoring of shop floor activities and conducting training to IPQA.
• Preparation, review and implementation of Standard Operating Procedures (SOPs) as per regulatory and internal QMS requirements.
• Participation in process validation activities including preparation and review of

      validation protocols and reports.

• Execution of cleaning validation and hold time study sampling and documentation.

Adcock Ingram Healthcare Pvt Ltd

• Review of BMR, BPR and raw material specifications and trending of results.
• Preparation and review of Master Batch Manufacturing and Packaging Records.
• Compilation and review of APQR reports and quality trending.
• Coordination of internal audits and customer audit compliance.
• Handling document issuance and document control activities.
• Compilation and review of Annual Product Quality Review (APQR).
• Handling of deviations, CAPA and change control documentation.

Pulse Pharmaceuticals Ltd |

• Participation in process validation activities including preparation and review of validation protocols and reports.
• Execution of cleaning validation and hold time study sampling and documentation.
• Monitoring critical process parameters (CPP) and critical quality attributes (CQA) during validation batches.
• Coordination with production and quality control departments for validation batch execution.
• Review and approval of validation documents ensuring compliance with regulatory guidelines.

Pellets Pharma Ltd

• Issuance of line clearance during manufacturing and packaging stages ensuring absence of cross contamination and mix-up.
• Performing in-process checks including verification of blend uniformity, compression
• parameters, coating parameters and packaging quality checks.
• Monitoring dispensing activities of raw materials and ensuring correct material issuance and reconciliation.
• Sampling of raw materials, in-process materials, finished products and validation batches as per sampling procedures.
• Monitoring environmental conditions including temperature, humidity and differential pressure records.
• Review of equipment logbooks, calibration records and preventive maintenance records.
• Identification and documentation of deviation during shop floor monitoring.
• Immediate communication to production and QA management regarding the deviation.
• Assessment of product impact and segregation of affected materials or batches If required.
• Initiation of deviation report as per SOP and participation in root cause investigation.
• Implementation of corrective and preventive actions and effectiveness verification.
• Documentation of observation closure and compliance verification.

Awarded star performer of the year for the period of March 2018, August 2021, April 2022.

• Reviewing of Finished product Certificate of Analysis with respect to Product specifications and approving the FPCOA’s.
• Verification of OOS, OOT before batch release for the products which are undergone for release.
• Preparation of BRC after batch release.
• Handling of dispatch activity for Export and Domestic market.

• EU GMP Audit conducted by the Hungary regulatory Authority.
• WHO GMP Audit
• ISO 9001:2008
• Sanofi Aventis Global QA audit and other customer audits.

• File Director
• Excel
• Win-Client
• QMS-Caliber
• Outlook
• Microsoft teams.
• MS office includes MS Word, MS Excel, and PowerPoint.
• DMS
• NECHLON

• Hard working
• Disciplined
• Problem solver
• Communication skills

I hereby declare that all the information provided above is true, complete, and correct to the best of my knowledge and belief. 

Date: 

Place: Bengaluru HARSHIT KUMAR RAM