Digambar Nalwad
M Pharmacy
Ahmedpur
Summary
To be a part of the challenging team which strives for the better growth of the organization and which explores my potential and provides me with the opportunity to enhance my talent with an intention to be an asset to the company.
Overview
10
10
years of professional experience
2015
2015
years of post-secondary education
3
3
Languages
Work History
Manager
MSD Pharmaceuticals Private Limited
04.2024 - Current
- Responsible for compilation, review and to ensure the high-quality chemistry, manufacturing, and control (CMC) documentation in eCTD format for regulatory submissions to US market.
- Coordinating and handling the compilation and post approval submission i.e. PAS, CBE‐30, CBE‐0 and Annual Reports to USFDA, using appropriate guidelines and regulations to maintain product life cycle.
- To ensure timely submission of supplement with least anticipated queries / no repeat queries.
- To ensure the submission of response to queries raised by regulatory agencies.
- To ensure through review and assessment of Change Controls.
- To review and compile manufacturing related documents i.e., Executed BMR and BPR, Intended BMR and BPRs, yield reconciliation, packaging components specifications, vendor documents and test data.
- To review and compile analytical documents i.e., Drug Substance/Drug Product/Excipients Specification, STP, COAs, Residual solvent data package, Method validation/ verification/transfer reports, Method equivalency reports, Stability data and Stability commitment.
- To actively participate in technical discussions and strategy preparation for evaluation of changes and planning of submissions.
- Well versed with ICH quality guidelines, USFDA regulatory guidance’s along with CDER Manual of Policies & Procedure and its applicability for evaluation and compilation of day to day submissions.
Assistant Manager-I
Biocon Pharma Limited
09.2022 - 03.2024
- Responsible for compilation, review and to ensure the high-quality chemistry, manufacturing, and control (CMC) documentation in eCTD format for regulatory submissions to US market.
- Coordinating and handling the compilation and post approval submission i.e. PAS, CBE‐30, CBE‐0 and Annual Reports to USFDA, using appropriate guidelines and regulations to maintain product life cycle.
- To evaluate DMF notifications received from DMF holders and taking appropriate actions.
- To ensure timely submission of supplement with least anticipated queries / no repeat queries.
- To ensure the submission of response to queries raised by regulatory agencies.
- To ensure through review and assessment of Change Controls.
- To ensure through review of Gap Assessment proposal of alternate vendor development for Drug Substance, Excipient and Packaging material.
- To review and compile manufacturing related documents i.e., Executed BMR and BPR, Intended BMR and BPRs, yield reconciliation, packaging components specifications, vendor documents and test data.
- To review and compile analytical documents i.e., Drug Substance/Drug Product/Excipients Specification, STP, COAs, Residual solvent data package, Method validation/ verification/transfer reports, Method equivalency reports, Stability data and Stability commitment.
- To provide accurate compliance information (Approval Summary Package) to stakeholders for implementation at user end.
- To ensure the compilation of eCTD publishing (using Lorenz DocuBridge) and submit the same through ESG to USFDA.
- To actively participate in technical discussions and strategy preparation for evaluation of changes and planning of submissions.
- Well versed with ICH quality guidelines, USFDA regulatory guidance’s along with CDER Manual of Policies & Procedure and its applicability for evaluation and compilation of day to day submissions.
Scientist-I
Aurobindo Pharma Limited
05.2019 - 09.2022
- Responsible for compilation, review and to ensure the high-quality chemistry, manufacturing, and control (CMC) documentation in eCTD format for regulatory submissions to US market.
- Coordinating and handling the compilation and post approval submission i.e. PAS, CBE‐30, CBE‐0 and Annual Reports to USFDA, using appropriate guidelines and regulations to maintain product life cycle.
- Evaluated DMF notifications received from DMF holders and taking appropriate actions.
- Ensured timely submission of supplement with least anticipated queries / no repeat queries.
- Ensured the submission of response to queries raised by regulatory agencies.
- Ensured through review and assessment of Change Controls.
- Reviewed and compiled manufacturing related documents i.e., Executed BMR and BPR, Intended BMR and BPRs, yield reconciliation, packaging components specifications, vendor documents and test data.
- Reviewed and compiled analytical documents i.e., Drug Substance/Drug Product/Excipients Specification, STP, COAs, Residual solvent data package, Method validation/ verification/transfer reports, Method equivalency reports, Stability data and Stability commitment.
- Provided accurate compliance information (Regulatory Commitment Package) to stakeholders for implementation at user end.
Assistant Manager (R1A)
Dr. Reddy’s Laboratories
12.2017 - 05.2019
- Ensuring cGMP and required SOP’s are followed during manufacturing and packing operations.
- Review of Completed Batch Production Records for Release.
- Compilation of batch document, Analytical Test Report, Technical Information Sheet and Product Release Request form for dispatch the batch/ Drug.
- Ensure collection of validation samples, stability samples as per approved protocol.
- Performing of activities such as line clearance, In process checks, AQL checks sampling, reconciliation of yields and reconciliation of packing material and finished goods products during routine operation.
- Actively performing sampling during process validation and cleaning validation activities.
- Aware with Electronic Batch Records System.
Officer
Viatris (Formerly known as Mylan Laboratories)
07.2015 - 12.2017
- Ensuring cGMP and required SOP’s are followed during manufacturing and packing operations.
- Performing of activities such as line clearance, In process checks, AQL checks sampling, reconciliation of yields and reconciliation of packing material and finished goods products during routine operation.
- Actively performing sampling during process validation and cleaning validation activities.
Education
M. Pharmacy - Pharmaceutics
NDMVP’s College of Pharmacy
B. Pharmacy - undefined
SSS’s. College of Pharmacy
HSC - undefined
Yeshwant Junior College
Ahmedpur, LaturSSC - undefined
Pravara Public School
Skills
Regulatory compliance
eCTD publishing
Change control assessment
Manufacturing documentation
Technical writing
Extra Curricular Activities/Conference Attended
Attended 64th Indian Pharmaceutical Congress, Chennai, 12/01/12 Lecture delivered at Lupin Limited on Pharmaceutics, 2014-2015 Won First Prize in Table Tennis Championship at Pharma Week Celebration, 12/01/15
Personal Information
- Date of Birth: 09/12/91
- Marital Status: Married
Declaration
- I Digambar Nalwad hereby declare that the basic information is true to best of my knowledge.
Timeline
Manager
MSD Pharmaceuticals Private Limited
04.2024 - Current
Assistant Manager-I
Biocon Pharma Limited
09.2022 - 03.2024
Scientist-I
Aurobindo Pharma Limited
05.2019 - 09.2022
Assistant Manager (R1A)
Dr. Reddy’s Laboratories
12.2017 - 05.2019
Officer
Viatris (Formerly known as Mylan Laboratories)
07.2015 - 12.2017
B. Pharmacy - undefined
SSS’s. College of Pharmacy
HSC - undefined
Yeshwant Junior College
SSC - undefined
Pravara Public School
M. Pharmacy - Pharmaceutics
NDMVP’s College of Pharmacy
Similar Profiles
Supriya MohandasSupriya Mohandas
Marketing Department at MSD Pharmaceuticals Private LimitedMarketing Department at MSD Pharmaceuticals Private Limited
Prasanna RamamoorthyPrasanna Ramamoorthy
Sr. Specialist, Data Engineering at MSD PharmaceuticalsSr. Specialist, Data Engineering at MSD Pharmaceuticals
Farook Ahmed Sheik AhamathFarook Ahmed Sheik Ahamath
Medical Advisor at MSD Pharmaceuticals Pvt. LtdMedical Advisor at MSD Pharmaceuticals Pvt. Ltd
AJIT PRATAPRAO GORTEAJIT PRATAPRAO GORTE
Jr Design Engineer at INNOFITT SYSTEMS PVT LTDJr Design Engineer at INNOFITT SYSTEMS PVT LTD
Abhay BiradarAbhay Biradar
Member at IEEEMember at IEEE