Assistant Manager
Resume:
CURRICULUM VITAE
R. Dilip Kumar
Paruthipattu, Avadi, E-Mail: *************.**@*****.*** Chennai - 600071. Mobile: 996-***-****
Career Objective
To leverage my skills, experience, and qualifications in contributing meaningfully to a dynamic organization that values innovation and excellence, while providing a stimulating and competitive environment with opportunities for long-term growth and professional development. Total Years of Experience: 16 Years
Organization: Esjay Pharma Private Limited.
Designation: Assistant Manager
Duration: November 2023 – Till date
Organization: Eywa Pharma Private Limited.
Designation: Senior Executive
Duration: June 2019 – November 2023
Organization: Pfizer India Private Limited.
Designation: Executive
Duration: October 2015 – May 2019
Organization: Par Formulations Private Limited.
Designation: Associate Designer
Duration: May 2014 – October 2015
Organization: Orchid Healthcare.
Designation: Junior Officer
Duration: May 2009 – May 2014
Job Responsibilities
Esjay Pharma Pvt. Ltd.
Responsible for compilation and submission (Initial and Post Approval Submission) of generic products to US FDA.
Responding to agency queries of US FDA within the stipulated timelines.
Responsible for upload and publish submission documents in eCTD using pharmaREADY software.
Responsible for prepare the labeling documents aligned with Reference Listed Drug
(RLD)/Reference Standards (RS).
Responsible for prepare the Structured Product Labeling (SPL) based on the US Prescribing Information (USPI) of drug products in pharmaREADY.
Technical review for CMC documents (R & D and Plant) like, product development reports, method validation, process validation documents, batch processing records, specifications (API and Drug products), Certificate of Analysis, hold time studies, tablet divisibility studies, stability protocol/reports, to create high quality dossiers for solid oral dosage forms.
Setting of impurity limits as per ICH Q3A and Q3B
Setting of specifications for Drug Substance and Drug Product as per ICH Q6A
Review of stability protocol and reports in-line with ICH Q1A and Q1E.
Additional Skills
Expert in providing the document functional attributes to submission documents for US FDA agency submissions, “PDF functional” attributes such as bookmarking, linking, inherit zooming for bookmarks, links, PDF version 1.4 to 1.6, fast web view, proper branching of bookmarks and optimal page opening setting to document etc.
Expert in handling Adobe illustrator, Adobe InDesign, Adobe Acrobat and Microsoft office Tools. Eywa Pharma Pvt. Ltd.
A. Artwork’s of US and Europe Market
1. In the development, review and electronic compilation of labeling documents to align with RLD/Reference Product, company goals, and submission requirements for assigned ANDAs/Dossiers and ensure labeling meets all legal and regulatory requirements.
This includes preparing, editing and formatting of labeling components (Label, foil, carton) based on key line(s)/ machine drawing(s) using Adobe Illustrator Software.
Packaging insert/outsert and Medication guide based on size of packaging using Adobe InDesign Software.
Development of Structured Product Labeling (SPL) documents (content, data elements and site establishments) to ensure the alignment with associated application as well as applicable FDA regulations and guidance’s. Troubleshooting any validation errors received. SPL software well versed in PharmaReady and Pragmatic validator.
Documentation in support of Section 1.14.3.1 (FDA), Section 1.3.2 (Europe). 2. Responsible for preparation and submission of response to labeling queries from regulatory authorities.
3. In the development, review and approval of labeling documents for commercial purpose in timely manner and as per regulatory and company requirements.
This includes preparing, editing and formatting using Adobe Illustrator Software and Adobe InDesign Software.
Review and approval of QC proof and shade cards.
Serialization activities using TraceLink software.
Review and approval of artworks using GLAMS Tool. 4. Preparation and review of change controls pertaining to labeling related documents for all products (in submission and commercials).
B. Compiling and Publishing of ANDA for both US.
C. Review and approve of batch packaging records of submission and commercial.
Pfizer India Pvt. Ltd.
• The primary responsibility is to create or update pharmaceutical packaging artwork in support of finished goods products for all regions.
• This includes accessing Pfizer Artwork Request (PAR) tasks within the e-PALMs artwork management system and compiling artwork based on the tools provided within the systems workflows for artwork creation. The colleague is expected to perform this activity embodying a right first-time mentality.
• The Graphic Designer liaises with internal Labelling Coordinators (Plant Coordinators), Market Coordinators (ALIM), PGS network and external supply packaging sites and other artwork centers to achieve daily objectives.
• Gather essential information for artwork development and electronic job folder assembly: Editor’s copies, redlined or “clean” word documents, templates, annotated PDFs, packing site requirements and reference documents among others to ensure artwork is composed according to the instructions communicated through these set of documents.
• Communicate artwork development related project information and status to Plant Coordinators and packing sites in a timely manner.
• Participate in project/launch teams as needed.
• Coordinate the approval of printer’s proofs.
• Update artwork management systems as required.
• Advanced and proven knowledge and expertise in the use of graphic and content development software such as the Creative Suite Adobe tools set of products (InDesign, Illustrator, Acrobat, Microsoft Office among others)
• Interpret drawings and design templates or die lines for artwork purposes.
• Capable of understanding and providing guidance on packaging site operational elements such as component version control identifiers, location of lot/exp, varnish coverage, line coding areas, registration and or eye marks, and create artwork accordingly.
• Ability to learn and work within electronic computerized artwork management systems.
Par Formulations Private Limited
Designing packaging components container/bottle labels, Blister foil, Cartons, Package insert and Medication guide for medicinal products of various dosage forms viz. Tablets, Capsules and Oral Suspension for USA market.
Artwork Activities
Retrieve FDA approved RLD labeling and create labels (Carton, Container label, Blister foil) for Par’s generic product.
Preparation of package inserts medication guide and Side by side comparison of RLD label vs. Par’s generic label.
Preparation of artwork in Adobe Illustrator, Corel Draw, Adobe InDesign and Quark Xpress as per the dimensions and packaging details obtained from Production and Reference Listed Drug.
Designing artwork based on marketing request and Reference Listed Drug.
Preparing Structured Product Labeling (SPL) using Pharma ready software.
Creating Barcode for each of the Commercial artworks.
Updating NDC as and when received and maintaining archival for NCD numbers.
Maintaining Labelling Package Insert Check List.
Labeling Updates verification in FDA site.
Maintenance of ANDA and Commercial label artworks.
Review of all the commercial labelling components such as Shade Cards and Vendor Proofs.
Maintaining and updating CD inventory records for all regulatory submissions sent and received.
Archival of innovator label samples of US market.
Orchid Healthcare
Designing labels, cartons & leaflets for medicinal products of various dosage forms viz. Tablets, Capsules and Oral Suspension & Injectable for worldwide including USA and EUROPE markets. Artwork Activities
Preparation of mockups (artworks) for US & Europe regions, for submission to the Regulatory Authorities (namely US FDA, UK MHRA etc.) for their review & approval.
Preparation & Review of commercial artworks with respect to market specific requirements.
Preparation of artworks as per the customer requirements.
Updating the artwork status on a fortnightly basis.
Review of Packaging Material Specifications for the finalized artworks for all the products.
Preparation and Review of Change controls of artworks related to all the products.
Co-ordination with several departments (Packaging, Production and QA) for preparation, review and release of artwork for commercial productions and Artworks prepared for commercial productions.
Software Proficiency: Adobe Illustrator, Adobe InDesign, Adobe Photoshop, QuarkXPress, Certificated Courses: Multimedia & HDCA
Education Qualification: Bachelor of Computer Application (BCA) Declaration
I hereby declare and state that the given herein above are true to the best of my knowledge. Date: Yours truly,
Place: Chennai
R. Dilip Kumar
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