Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering more than 9 years of experience in pharmaceutical industry at different core area like Intermediates & API route of synthesis, formulation analytical method development and analytical method validation, and formulation Quality control, looking for a challenging new role.
Roles and Responsibilities:
· Since I have real time experience in API route of synthesis, significantly I can review DMF (Drug Master File) each and every section with analytical data evaluation. Participating in discussion with CFTs/3rd party (who provide DMF) and rectify all the issues and finalize DMF
· Review of MPC (Master Production Card) and providing guidance to production department as per regulatory requirement
· Review of PDR (Product Development Report) and providing guidance to R&D department as per regulatory requirement and preparing final PDR document as per CTD
· Review of Manufacturing process and preparing final document as per CTD requirement
· Review of Specifications, Standard Testing Procedures of Finished product, excipients and packaging materials against ICH guidelines and other pharmacopoeias
· As I have real time experience in doing Analytical Method Validation, significantly I can review AMVRs against ICH guidelines, evaluate, and provide new formats to CFTs (Cross functional teams) for AMVRs. Preparing final AMVRs to include in dossier as per CTD format.
· Having real time experience in stability samples testing, so significantly I can review stability data against ICH guidelines and prepare final stability data in GMP format to include dossier
· Having a good experience in comparison of in-house Analytical Method against pharmacopeial methods (e.g., Chromatography (USP-NF, Content uniformity by HPLC (USP-NF, pH USP-NF etc.,
· Having good experience in review of SOPs related to Quality department, Pharmacovigilance department, and SMF (Site master file), etc.,
· Having good experience in preparing CMC (Chemistry, Manufacturing and Control) sections for regulatory documents through product life cycle
· In current job profile, we (RA) department is collaboratively working with International business team, so I have a good communication and relationship with them in business prospective.
· Able to compile dossier to ROW countries and other country specific dossier compilation
· Able to compile dossier in CTD, eCTD and ACTD format.
· Plan and execute analytical experiments to develop new method for Assay, RS and Dissolution tests with systematic approach
· Significant experience with a broad variety of analytical techniques, such as liquid chromatography, Thin layer chromatography, titration and UV-Vis spectroscopy etc.,
· Well experienced in conducting troubleshooting for complex technical issues and to lead major characterization studies
· Having good understanding of technical and regulatory expectations regarding analytical development, analytical method validation and product characterization
· Preparation of Specifications and standard test procedures as per ICH (Q6B) guidelines
· Preparation of Analytical Method Validation Protocols as per ICH Q2(R1) guidelines
“Since I have good real time experience in plan, conduct and execute the analytical method development experiments, Analytical method validation. Thus, it is very much useful to review the documents required for registration as per ICH and other health authorities' requirements”.
Analytical Method development:
· Literature survey for new targets or projects
· Method development of drug products for Assay, Related Impurities and Dissolution by using HPLC based on QbD Approach to EU market e.g., rosuvastatin
· Method development of IR, DR, ER formulations using various dissolution Apparatus (USP-1 and USP-2)
· Method Comparison study for Compendia Methods and In-house Methods
· Mass Compatible Method Development for Related Impurities methods to isolate the impurities
Preparation of Method Development Plans and Reports.
Analytical Method validation:
· Experienced in analytical method validation of different tests such as Assay, CU, UOD, Dissolution and Related Impurities by Using HPLC/UV/TLC
· Well experienced in preparation of analytical method validation protocols and reports as per ICH guidelines
Transferring new analytical techniques to the Quality Control (QC) laboratory.
Quality Control Department:
· Performing Analysis of Finished, Stability, in process and raw materials samples by instrumental methods as per Specifications
· Responsible for Performing Analysis of Hold time study samples by instrumental methods as per Specifications
· Assist in the investigation and root cause analysis of analytical quality issues, including OOT/OOS results, generated during a study and execution of associated CAPA according to internal quality procedures
· Performing Analysis of Cleaning method Validation & Cleaning method validation by instrumental methods as per protocols
· Observing and complying with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
· Held responsibility to monitor and maintenance of HPLC, UV-Visible Spectroscopy, Dissolution apparatus and other instruments
· Calibration of Analytical Instruments like HPLC and UV-VIS Spectroscopy and Dissolution apparatus
· Responsible for Maintenance of reference standards and their Log books, expiry dates and proper consumption records
· Good experience in standardization of reagents to determine the exact concentration (molarity)
· Well experienced in analysis of blend and finished product samples by Titration techniques
· Participating in CFTs meeting along with CEO to discuss on technical issues and time lines
· Pro-actively completing the targets on time to meet the time lines
· Water for pharmaceutical purposes samples chemical analysis
· Dissolution samples testing by AAS instrumental methods.
Roles and Responsibilities:
· Expertise in carrying out Multi-step synthesis of organic molecules in gram scale to plant scale and their characterization.
· Developing feasible synthetic route for molecule of interest from raw material stage to final step.
· Expertise in transfer of Lab technology to pilot plant for commercialization
· Good experience in optimization, process development and pilot scale development for client-based products such as Novartis, GSK and Achillion.
· All the Novartis projects were developed, produced small scale batches, and successfully shipped to the client on time as per client requirement.
· Multiple steps synthesis of organic compounds and their characterization, Acid amine coupling and halo amine coupling, electrophilic substitution reactions, functional group interconversion such as alkylation's, acylation, protection and deprotection of various functional groups, esterification etc., Nitration, halogenation of aromatic and heterocyclic compounds.
· Plan and execute experiments on synthesis and purification of organic entities for process evaluation, development, and troubleshooting.
· Record and analyze scientific data/observations in detail. Write technical updates/reports. Daily update of Lab Note Book and experience writing client provided LNBs as per client requirements.
· Experience in using of “SAP software” for daily activities such as raising request to collect reagents, chemicals, raw materials, intermediates and raising A.R numbers for test samples and weekly report submissions…etc.
· Handled multiple projects with minimal supervision. Manage project timelines and deliverables· Experience in handling pyrophoric, oxidizing, reducing and other reagents using for the synthesis · Developing cost efficient and eco-friendly manufacturing process, minimizing effluents, reduction of process cycle time of APIs and intermediates · Well experienced in troubleshooting of pilot plant issues during experiment
· Strong synthetic skills demonstrated by synthesis and isolation (chromatography, crystallization, distillation etc.) as well as characterization (NMR, IR, MS etc.) of organic compounds.
· Use a variety of analytical methods to monitor reaction processes
· Improve existing processes to reduce cost and increase reliability, purity, and safety
· Maintain familiarity with regulatory regimes, including current good manufacturing practices and chemical hygiene plans.
· Ensure compliance of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in the manufacturing facility.
· Evaluating documentation and operations according to company procedures.
· Preparation of master documents (like Standard Operating Procedures, Equipment Operating Procedures and Equipment Cleaning Checklists).
· Preparation and review of Batch Manufacturing Records, Packing and Dispatch Records.
· Analytical data interpretation of Assay (HPLC), Related substances (HPLC and TLC), 1H NMR, 13C NMR, LC-MS, P-XRD, particle-size distribution, Metal content, ROI, ROE, Heavy metals, UPLC and specific optical rotation.
Roles and Responsibilities:
· First three Months - Training Period.
· Assisting to superiors in planning and executing of organic reactions
· Purification of Reaction products & isolation of impurities by Column chromatography
· Excellent understanding of passion for safe work procedures & practices
· Maintaining laboratory journals & records as per procedure
Co-ordination with QC/QA Department & initiate corrective actions if required.
· Successfully completed the evaluation and comparison of in-house analytical procedures against USP-NF pharmacopeia methods (e.g., Microbial test, Optical rotation, solubility, pH, Water determination, Bacterial endotoxin, Sterility, Sub-visible particles, Visible Particles, Color and clarity).
· Generated the new formats as per GMP for Analytical method validation reports (Assay, RS, Bacterial endotoxin, and sterility tests)
· Successfully completed thymalfasin “Dossier compilation” for India, panama, Philippine's and Vietnam in CTD format
· Participated and successfully completed company's internal program “WCM” (World Class Management- International Registration Efficiency Improvement) in which all the CFTs will be participated weekly once and discuss on project issues and time lines
· Successfully completed the evaluation and review of thymalfasin, thymopentin and atosiban “DMFs” (Drug master files).
· Successfully resolved the queries received from agent on submitted projects within the timeline.
· Introduced new formats for Analytical Method Validation protocols and Reports as per GMP.
· Introduced new changes in existing systems like good documentations etc.,
· Successfully achieved the well separation between “Flurbiprofen peak” and adjacent impurity peaks and set method for assay test.
Since the Flurbiprofen transdermal patches product was very critical and complex, successfully developed an analytical method for dissolution (Delayed release-24hours), Assay and Related substances tests.
· Participated in EU audit from beginning to ending and involved in each process of audit from Analytical development laboratory and Quality Control departments. Successful completed the EU audit with approval
· Successfully developed analytical method for Rosuvastatin, Quetiapine and Olmesartan products
· Increased the output ratio of release batches almost two time than actual output by doing smart work and got appreciation from department head
· Successfully completed evaluation and testing of OOS samples for many products like Torvast tablets, Omace Tablets, Lohist Syrup, etc. and involved in group discussions to find out route cause
· Successfully achieved the sample preparation for critical products like Omathrocin oral suspension (Reconstitution process)
· Successfully achieved solutions for critical dissolution issues like Omafen oral suspension
· Successfully completed trainings on ALCOA, ALCOA+ and other GMP trainings
· Successfully resolved dissolution by AAS (Atomic Absorption Spectrometry) issues like Calcy 600mg tablets, Ironic capsules, etc
· Successfully set a “Titration method” for Omacid tablets
· Successfully developed “TLC method” for Naproxen tablets
· Successfully closed all the “Lab incidents”, “Deviations”, “OOS”, and other documents on time with proper justification without fail
· Significantly held role as a responsible person of reference and working standards till end of my working day.
· Successfully optimized the “multi-step route of synthesis” of “Achillion project”
· Worked in “clean area” for Achillion project and handled production scale batches with proper GMP process.
· Achillion project, handled KG level batches filtration by using bulk size “Centrifuge filtration equipment” in production
· Achieved many “reduction reactions” (pressure reactions) of “Achillion” project using “Autoclave instrument” as per defined “Standard Operating Procedure of autoclave instruments”
· Achillion project, successfully achieved good separation of critical intermediate steps using lab scale “Preparative HPLC technique” and production scale “Column Apparatus Technique”
· Novartis project, successfully three years worked as an FTE (Full time employee) and achieved many targets on time and obtained appreciation from “Novartis clients”.
· Novartis project, successfully completed yearly minimum two projects and shipped to client.
· Novartis project, optimized route of synthesis of new molecules using different techniques such as “Parallel synthesizer” (To perform multiple reactions at a time), “Isolera instrument” (Preparative HPLC-purification technique), “Rotary vacuum dryer” (Material drying), “Manual filtration equipment” (Reaction mass filtration), “advanced mass separation technique” (Used to separate two different density solvent in the reaction mass), etc.
· Novartis project, successfully completed project targets before the timeline and got “best performer award” from organization as well as “Team award” from client.
· Novartis project, got appreciation from global EHS (Environmental Health and Safety) head for handling and controlling of “fire accident” in the lab premises as a lab EHS in-charge.
Successfully held roles as “LAB EHS coordinator”, “Lab housekeeping in-charge” and “Lab cold room in-charge”
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:
Job Titles Held: