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Diptanshu P. Email & Phone Number

QA Area Specialist III at Novo Nordisk
Location: Dayton, Ohio, United States 7 work roles 2 schools
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Current company
Novo Nordisk
Role
QA Area Specialist III
Location
Dayton, Ohio, United States
Company size
2241 employees

Who is Diptanshu P.? Overview

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Quick answer

Diptanshu P. is listed as QA Area Specialist III at Novo Nordisk, a company with 2241 employees, based in Dayton, Ohio, United States. AeroLeads shows a matched LinkedIn profile for Diptanshu P..

Diptanshu P. previously worked as Quality Assurance Associate III at Alkermes and Quality and Compliance Specialist at Piramal Pharma Solutions. Diptanshu P. holds Haccp Quality Auditor Certificate, Medicinal And Pharmaceutical Chemistry from Pharma-Medica Science College Of Canada.

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Email format at Novo Nordisk

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Novo Nordisk

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Profile bio

About Diptanshu P.

- Possess M.S. In Chemistry degree, with over 15 years of experience in quality control and assurance in the pharmaceutical industry. - I am a dedicated professional skilled in ensuring the highest standards of quality, compliance, and safety. - As a certified HACCP Quality Auditor, I have expertise in reviewing scientific documents, analyzing analytical test results, and implementing corrective actions across various production operations.- I possess extensive knowledge of industry standards, including SOP, STP, STM, and analytical tech transfer, and I am proficient with advanced software and laboratory systems such as OPENLAB, LAB-X, ICP-MS, and LIMS. - My proficiency extends to maintaining department metrics in line with key performance indicators (KPIs), demonstrating my commitment to operational excellence. - Passionate about upholding quality and safety, I strive to contribute effectively to every stage of pharmaceutical development and manufacturing.Good Manufacturing Practices (GMP): In-depth knowledge of GMP requirements for the pharmaceutical industry.- Regulatory Knowledge: Familiarity with regulatory requirements from agencies like the FDA, Health Canada and ICH guidelines.- Quality Control and Assurance: Understanding of quality control processes, including testing, sampling, and documentation.- Problem Solving and Root Cause Analysis: Strong analytical skills to investigate deviations, non-conformances, and product issues.- Risk Management: Knowledge of risk-based approaches to ensure product quality and compliance.Project Management: Ability to manage multiple quality initiatives, audits, and inspections.

Current workplace

Diptanshu P.'s current company

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Novo Nordisk
Novo Nordisk
QA Area Specialist III
Lebanon, NH, US
Website
alkermes.com
Employees
2241
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7 roles

Diptanshu P. work experience

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Quality Assurance Associate Iii

Current
Alkermes

Ohio, United States

  • Led a quality team consisting of QA reviewers, QC analysts and Quality inspectors providing overall guidance, training, scheduling, assisting with hiring process.
  • Investigated incident associated with production operation and provide on-time SME support to the production unit.
  • Collaborated with production, QA team and cross functional teams to address quality-related issues promptly.
  • Investigated deviations, out of specification results as part of team to determine product impact and find out root cause and corrective-preventative measures (CAPA).
  • Reviewed batch manufacturing records, QC analysis results, quality patterns, deviations for completeness, accuracy, data integrity and took determination actions like hold, release, and rejection of the batch.
  • Identified opportunities for process improvement and contribute to initiatives aimed at right at first time (RFT), enhancing the efficiency and effectiveness of in-process QA activities.
Apr 2024 - Present

Quality And Compliance Specialist

Piramal Pharma Solutions

Riverview, Michigan, United States

  • Performed QC data review of Active Pharmaceutical Ingredient (API), Raw Materials, Starting Materials, In-process samples and finished products.
  • Verified analytical tests result calculations against the specifications and test methods for data discrepancies, escalating the issue to the manager.
  • Participated in investigations of out-of-specification or out-of-trend analytical results.
  • Ensured that documentation is in accordance with established SOPs and followed ALCOA ++ principles.
  • Verified that laboratory instruments are calibrated, analytical data records and their logbooks are maintained.
  • Worked closely with QA department to address any quality related issues and facilitate compliance.
Aug 2022 - Jan 2024

Quality Assurance Associate

Bausch Health Companies Inc.

Steinbach, Manitoba, Canada

- QA lead for an atypical situation and investigations associated with production operation including floor presence to provide on-time support, assessment of product impact using problem-solving tools, determination of root cause, corrective and preventive measures (CAPA)- Make sure current copy of approved change control, deviation reports (DR) and.

Aug 2018 - Jul 2022

Chemist (Qc Document Reviewer)

Bausch Health Companies Inc.

Steinbach, Manitoba, Canada

- Performed timely data review for quality and integrity of API drug substances, excipients, in-process materials, finished products, stability study, analytical method validation documentation, microbiological testing of cleaning validation and verification- Ensured accuracy, completeness and neatness of analytical documentation- Verified documented.

Mar 2015 - Aug 2018
Team & coworkers

Colleagues at Novo Nordisk

Other employees you can reach at alkermes.com. View company contacts for 2241 employees →

NR Nadine Rauch Nadine Rauch Colleague at Novo Nordisk Lemont, Illinois, United States, United States View → CL Christina Luongo Christina Luongo Colleague at Novo Nordisk Brookfield, Connecticut, United States, United States View → DB Dan Bellair Dan Bellair Colleague at Novo Nordisk Lockport, Illinois, United States, United States View → DT Deborah Tufts Deborah Tufts Colleague at Novo Nordisk United States, United States View → M( Molly (Wehrenberg) Weber Molly (Wehrenberg) Weber Colleague at Novo Nordisk Fremont, Indiana, United States, United States View → SL Stephanie Leforge Stephanie Leforge Colleague at Novo Nordisk Wilmington, Ohio, United States, United States View → MH Mary Harris Mary Harris Colleague at Novo Nordisk Dayton, Ohio, United States, United States View → MC Mariel Culp Mariel Culp Colleague at Novo Nordisk Cincinnati, Ohio, United States, United States View → JM Jane Mccormick Jane Mccormick Colleague at Novo Nordisk Wilmington, Ohio, United States, United States View → JE Jamie Engel Jamie Engel Colleague at Novo Nordisk Carmel, Indiana, United States, United States View →
2 education records

Diptanshu P. education

Haccp Quality Auditor Certificate, Medicinal And Pharmaceutical Chemistry

Pharma-Medica Science College Of Canada
FAQ

Frequently asked questions about Diptanshu P.

Quick answers generated from the profile data available on this page.

What company does Diptanshu P. work for?

Diptanshu P. works for Novo Nordisk.

What is Diptanshu P.'s role at Novo Nordisk?

Diptanshu P. is listed as QA Area Specialist III at Novo Nordisk.

Where is Diptanshu P. based?

Diptanshu P. is based in Dayton, Ohio, United States while working with Novo Nordisk.

What companies has Diptanshu P. worked for?

Diptanshu P. has worked for Novo Nordisk, Alkermes, Piramal Pharma Solutions, Bausch Health Companies Inc., and Teva Pharmaceuticals.

Who are Diptanshu P.'s colleagues at Novo Nordisk?

Diptanshu P.'s colleagues at Novo Nordisk include Nadine Rauch, Christina Luongo, Dan Bellair, Deborah Tufts, and Molly (Wehrenberg) Weber.

How can I contact Diptanshu P.?

You can use AeroLeads to view verified contact signals for Diptanshu P. at Novo Nordisk, including work email, phone, and LinkedIn data when available.

What schools did Diptanshu P. attend?

Diptanshu P. holds Haccp Quality Auditor Certificate, Medicinal And Pharmaceutical Chemistry from Pharma-Medica Science College Of Canada.

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