Summary
Overview
Work History
Education
Skills
Certification
Skills Achievements
Skype Id
LinkedIn Profile Url
Career Experience
Passport
Personal Information
Accomplishments
Affiliations
Languages
Work Availability
Interests
Making new friends
Timeline
Intern
SAMADHAN PATIL

SAMADHAN PATIL

Pharmaceutical QA-QMS Consultant (CQA)
Mumbai,Maharashtra

Summary

Bachelor of Pharmacy with over 7.5 years of comprehensive experience in Quality Assurance. Proficient in Quality Management Systems, adept at conducting both internal and external audits, and ensuring compliance. Skilled in supplier qualification, equipment qualification, validations, and in-process quality assurance for Small Volume Parenteral (SVP), Large Volume Parenteral (LVP), and Oral Solid Dosage (OSD) and Liquid formulations and Medical Devices. Demonstrated expertise in maintaining rigorous Contract Manufacturing Organization (CMO) documentation standards.

Overview

7
7
years of professional experience

Work History

QA- QMS Consultant (CQA)

Crescent Pharma Ltd. UK
08.2022 - Current
  • Performing the roles and responsibilities according to the requirements of European CGMP, GDP, MHRA, and USFDA outlined as follows:
  • Management of all QA requirements for Contract Manufacturing Organizations (CMOs), which includes internal and external audits, deviations, OOS, change requests, CAPA, quality agreements, validation, manufacturing batch records, and product release.
  • Liaison with subject matter experts to ensure organizational compliance with applicable Good Manufacturing Practice (GMP) regulations.
  • Oversee the QA aspects of a network of suppliers and co-development partners to maintain compliance and ensure project progress meets the required quality standards.
  • Develop and uphold the CMO quality system and associated processes, providing strategic guidance to leadership and project teams on CMO and GMP-related issues.
  • Conduct quality assurance activities, including validation protocol/report review and approval, specification review and approval, batch record review and release, to guarantee the timely delivery of finished products.
  • Adhere to established quality systems procedures for proper GMP compliance, encompassing change control, deviations, complaints, and training.
  • Maintain supporting documentation for products, suppliers, and quality systems in line with company and industry standards.
  • Supporting PQR management, inspections, Supplier qualification and Artwork Management System
  • Conduct GMP internal audits and on-site audits of contracted CMOs, API and intermediate manufacturing sites, primary packaging manufacturing sites, excipients, and finished products manufacturing sites.

Senior QA Officer

ARAUPHAR SARL INDUSTRIE PHARMACEUTIQUE
01.2018 - 05.2022
  • Performed the roles and responsibilities according to the requirements of DPM/ WHO, CGMP, GDP outlined as follows:

Executive

Cipla Ltd.
07.2016 - 12.2017
  • Performed the roles and responsibilities according to the requirements of USFDA, MHRA, CGMP, and GDP as outlined below:
  • Supervision & maintenance of the sterile batch preparation area, filling area, and washing section of Liquid Parenteral.
  • BMR Activities: Preparation of product-related BMR in coordination with the production department; review of Master BMR; maintaining the master documents once prepared, preparation of MMF (Master Formula Record), review of executed batches (BMR/BPR); media fill and process validation protocol and reports; and preparation and review of SOPs, process validation, and cleaning validation protocols.
  • PQR activities:
    • Preparation of PQR calendar, Preparation of PQR as per calendar, Collecting, tabulating all data required for preparation of PQR as per SOP, Reviewing of BMR, BPR and QC data like Finished product COA, API COA, stability data sheets and collecting the data for PQR
    QMS:
    • Deviations: Ensure investigations of process deviations are appropriately performed and documented. Timely closure of deviations.
    • Change Control: Review of change control for assessment of the impact of change & change implementation review.
    • CAPA: Ensure appropriate corrective and preventive actions are identified and implemented for non conformances.

Education

B. Pharmacy -

R.C. PATEL Institute of Pharmaceutical Education & Research, KBC, North Maharashtra University, Jalgaon
01.2016

HSC - undefined

Rashtriya Vidyalaya Jr. College, Chalisgaon, Nasik Board
01.2012

SSC - undefined

Madhyamik Vidyalaya Gondgaon, Nasik Board
01.2010

Skills

  • Comprehensive understanding of global Con-siteGMP for the product lifecycle for pharmaceuticals/medical devices
  • In-depth knowledge of MHRA, EU GMP, and US FDA regulations (21 CFR, 210, 211, 820)
  • Skilled in CMO management and processes
  • Adept at negotiating and implementing quality agreements
  • Quality Management System (Change Control, Deviation, OOS, CAPA, Market Complaint, Investigation and Recall), Product Quality Review Management, Validations and Qualifications,
  • Review of CMO documents (Batch records, validation/qualification reports, stability reports, PQR, and other QMS elements)
  • Audit planning, conducting (supplier and CMO's on-site audit and internal audit), and ensuring regulatory inspection compliance

Certification

  • IDP certified IELTS-General Test achieved Band 6
  • Certified by Development and Language School Kinshasa, RDC-Africa, for completion of the "Advanced Level French Language" course.
  • Lean Six Sigma Yellow Belt Certified.

Skills Achievements

  • Microsoft Operating Systems: Windows 10, 11, and Microsoft Outlook 365.
  • Knowledge of MS Office, Word, Excel, PPT, Outlook, etc.
  • Ability to work both independently and as part of a team
  • Understanding of GMP
  • Regulatory Knowledge: Familiarity with the USFDA and other regulatory guidelines.
  • Project Management: Ability to manage schedules, resources, and project deliverables.
  • Negotiation for creating mutually beneficial agreements.
  • Risk Management: Identifying and mitigating potential risks.
  • Communication: Clear and effective interaction with various stakeholders.
  • Problem-Solving: Addressing and resolving issues as they arise.
  • Strategic Planning: Developing long-term strategies for successful collaboration.
  • Relationship Management: Building and maintaining strong professional relationships.
  • Achievement: In the absence of the QA Manager, I performed all the roles and responsibilities of the QA Manager for 10 months in the LVP plant and passed WHO and customer audits.

Skype Id

live:.cid.2febb4bb55993a98

LinkedIn Profile Url

https://www.linkedin.com/in/samadhan-patil-0b6b6713a

Career Experience

7.5 years

Passport

Available

Personal Information

  • Date of Birth: 10/10/93
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married

Accomplishments

HVAC system: Reduced frequency/sleep mode validation during product changeover. Saved the cost of $7500 USD per year, for the area where maximum time was required to complete the product/mold changeover.

Affiliations

  • IDP certified IELTS-General Test achieved Band 6
  • Certified by Development and Language School Kinshasa, R.D. Congo-Africa, for completion of the “Advance Level French Language” course.
  • Lean Six Sigma Yellow Belt Certified.

Languages

Hindi
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
French
Upper intermediate (B2)

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Interests

Watching films

Listening to music

Travelling

Making new friends

I begin by saying hello and introducing myself. Next, I ask them general questions, such as what they do for fun or how they spend their time. I Try to avoid topics that might make them uncomfortable, like sharing political beliefs or personal information.

Timeline

QA- QMS Consultant (CQA)

Crescent Pharma Ltd. UK
08.2022 - Current

Senior QA Officer

ARAUPHAR SARL INDUSTRIE PHARMACEUTIQUE
01.2018 - 05.2022

Executive

Cipla Ltd.
07.2016 - 12.2017

B. Pharmacy -

R.C. PATEL Institute of Pharmaceutical Education & Research, KBC, North Maharashtra University, Jalgaon

HSC - undefined

Rashtriya Vidyalaya Jr. College, Chalisgaon, Nasik Board

SSC - undefined

Madhyamik Vidyalaya Gondgaon, Nasik Board
SAMADHAN PATILPharmaceutical QA-QMS Consultant (CQA)