Niranjan Mp Kumar Email & Phone Number

Dungarvan, Ie

Dungarvan, County Waterford, Ireland

• Conducted routine and wet chemistry testing of finished products and stability samples, ensuring strict compliance with GLP and cGMP procedures (pH, CCIT by UV, Appearance, Clarity-Turbidimeter, Colour, KF-Oven, Phosphate Identification, N Tail Determination by HPLC, Volume in Container).• Provided technical support and training to other analysts in laboratory techniques.• Assisted in the transfer of analytical methods into the QC laboratory as required.• Reviewed quality data, including PQR (Product Quality Review), quality events, and Empower reports.• Created validation approaches and protocols, performed validation lab work, and drafted SOPs, risk assessments, anomaly investigations (OOS/OOT, root cause analysis, deviations, and exceptions), and change control support documents under cGMP guidelines.• Conducted weekly audits with the team to maintain laboratory standards on-site.• Performed controlled drug testing (e.g., midazolam) using various methods such as assay, FT-IR, and CU.• Experienced in handling, storing, and disposing of controlled drug samples and standards.• Led numerous LEAN projects, including creating pre-formatted notebooks, optimizing the data entry and review process, updating SOPs in a timely manner, and serving as the SME for SIMS (Seal Integrity Monitoring System)

Dublin, County Dublin, Ireland

● Business improved under the new management. ● Responsible for ensuring that the clinics are well led, operate efficiently, and deliver the required client volumes and financial performance.● Establishing Policies and procedures that support high–quality healthcare service, in partnership with hospital management, medical teams, and the surrounding community. ● Attention to detail: responsible to see, investigating, researching, developing, and establishing new services.● Responsible for increasing the revenue for the company along with excellent patient care, overseeing the Marketing team, and aiding with the new marketing strategy.

Dublin, County Dublin, Ireland

● Manage a team of Supervisors and Operators to ensure the production plan is delivered to the highest standard.● Manage Daily Production Line Start-Up and Shift Handover to optimize factory efficiencies.● Execution of daily production plans to meet the daily schedule and optimize factory efficiencies,● Ownership of Health & Safety Management routines to ensure compliance.

Bengaluru, Karnataka, India

Job Responsibilities: • Carry out routine analytical testing -UV Spec, Auto titration, Density, pH and HPLC on investigation works as per the timeline and troubleshoot the process-related problem.• Drafted quality assurance policies, SOP’s, and record control processes to ensure accuracy. • Performs laboratory studies, projects, and processes/initiatives.• Assists in developing lab strategies, policies, and guidelines linked to the area of expertise (for example, authoring Standard Operating Procedures).• Performing Sample Management activities to support QC testing.

Bengaluru, Karnataka, India

•My Internship was about Quality control and Quality assurance in Vesper Pharmaceuticals, tocheck and verify the amount of Active Pharmaceutical Ingredient present in the respective formulations (injections). Here, I learned how to handle and the equipment (UV spectrometer, HPLC, autoclave, etc.) and the utilization of chemicals. Maintained the records of tested products - Raw material to finished product. Supervising the workers in the pharmaceutical plant and checking the sterility of the environment.

Vijayanagar, Bangalore

Managed all operations around data entry, verification, and validation relevant to Pharmacy Council registration certificates database. Achieved operational excellence by coordinating and integrating manual data entry process with microchip technology-enabled scanning and verifying.

Master'S Degree, Pharmaceutical Regulatory Affairs

Activities and Societies: Completed my research and did my dissertation on the topic "GLOBAL REGULATORY PROSPECTIVES ON COVID-19 VACCINE.

Bachelor'S Degree, Pharmacy (B Pharm), Gpa: 3 (Cgpa: 7.89)

Revelent Course work: • Human Anatomy & Physiology • Biochemistry •Pharmaceutical/Medicinal Chemistry •Pharmaceutical Biotechnology •.

Pre-University, Physics, Chemistry, Mathematics And Biology, Gpa: 3.08 (Percentage: 77.16%)

Schooling