Shuva Guha
Scarborough,Canada
Summary
To grow with a leading organization that utilizes my abilities to the fullest extent possible, helping me realize and develop my potential and be a part of a team that scales great heights through the continuous learning process and utmost dedication.
Overview
8
8
years of professional experience
5
5
Certification
Work History
Senior Executive, Global Regulatory Affairs
The ACME Laboratories Ltd.
2021.03 - 2024.06
- Prepare the Regulatory requirements to register a product in RoW market
- Assist to review/Review the compiled Registration Application Document as per internal SOP/Work Instruction to ensure compliance with country specific regulatory requirements for error free submission
- Assist to develop & write clear arguments & explanation for new product registration ®istration renewals
- Assist to submission of License variations and renewals for RoW market meeting the deadline
- Communicate with respective department/division for supporting documents to prepare Registration Application Documents
- Conduct training & knowledge sharing session on regulatory guidelines of respective country to keep updated about regularity issue
- Arrange meeting with cross-functional department to resolve the pending issues to accelerate product registration in RoW market.
Executive, Quality Assurance
ORION PHARMA LIMITED
2016.08 - 2021.02
- Responsibilities in IPQC (In Process Quality Control):
1. In process parameters checking at coating, encapsulation, primary and secondary packing stage.
2. Responsible for performing physical parameters checking of tablets /capsules.
3. Sampling of intermediate, bulk, finished product, retention sample, microbiology sample and real
time stability sample.
4. Responsible for line clearance of all area as per written procedure.
5. Responsible to attach and check approved label on container.
6. Approval of printing advice sheet
7. Finished product quantity check before batch release.
8. Responsible for participation in process validation activities.
9. Checking of the weight of some API and excipients during manufacturing at PFS section.
10. Checking of other GMP documents.
- Responsibilities in FRC (Foreign Regulatory Compliance):
1. Work with Product Development, Quality Assurance, and management to prepare and review
international Regulatory submissions, design dossiers, and other international filings as CTD, ACTD
to obtain products registration or marketing clearance.
2. Submit documents and timely responses to the queries with international Regulatory bodies.
3. Provide Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as
these changes pertain to international regulations.
4. Review design changes and technical files for updates to documentation.
5. Review validation protocols and task reports, ensuring compliance with Standard Operating
Procedures during Dossier Review.
6. Work with Production, Procurement, QA and QC on Supplier Qualification and maintenance.
7. Work closely with Quality and Regulatory Affairs to assemble and prepare and provide regulatory
submission documentation.
Education
Masters of Pharmacy (M. Pharm) -
01.2015
Bachelor of Pharmacy (B. Pharm) -
01.2014
Skills
- Photography
- Cooking
- Microsoft Office
- Excel
- PowerPoint
- Adobe PDF
- Photo editing software like Adobe Lightroom etc.
Certification
- Registered Pharmacist by the Pharmacy Council of Bangladesh (Register “A”), A-9874
- Complete 2 days long training session on ‘Kaizen & 5S for operational excellence’, 12/01/22
- 3 days training program on “Advanced Excel for Advanced Learners’, 06/01/23
- Complete 2 days long training session on ‘Strategic Leadership development’, 12/01/23
- 3 days training program on “Microsoft Excel for the Basic to Advance Learners”, 06/01/22
Accomplishments
Achieved best employee award in 2023.
Languages
English
Professional Working
Bengali
Native or Bilingual
Hindi
Limited Working
Timeline
Senior Executive, Global Regulatory Affairs - The ACME Laboratories Ltd.
2021.03 - 2024.06
Executive, Quality Assurance - ORION PHARMA LIMITED
2016.08 - 2021.02
University of Science & Technology, Chittagong - Masters of Pharmacy (M. Pharm),
University of Science & Technology, Chittagong - Bachelor of Pharmacy (B. Pharm),
- Registered Pharmacist by the Pharmacy Council of Bangladesh (Register “A”), A-9874
- 3 days training program on “Microsoft Excel for the Basic to Advance Learners”, 06/01/22
- Complete 2 days long training session on ‘Kaizen & 5S for operational excellence’, 12/01/22
- 3 days training program on “Advanced Excel for Advanced Learners’, 06/01/23
- Complete 2 days long training session on ‘Strategic Leadership development’, 12/01/23
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