SAP, ERP, Minitab, Electronic Lab Notebook (ELNs), Proficient with Microsoft Office (Word, Excel & Power point)
Vijay Pal Singh Sikarwar
Scientist – MSAT (Process Development/Technology Transfer)
Hyderabad,Telangana
Summary
With over 11+ years of experience in the pharmaceutical industry a highly skilled professional in Quality Assurance, Process Development, Technology Transfer, Site Transfer, Process Validation, Process optimization, Trouble shooting, commercial launch & manufacturing compliance in oral solid dosage form for various regulated market (USA, Europe, Canada, Australia ,Brazil), with a broad range of experience in various dosage form such as Tablets, Hard Gelatin & Soft Gelatin capsules, Oncology Products, MUPS and pellets.
I offer expertise in all facets of Process Development, Process Optimization, Trouble shooting, Scale up & Technology Transfer. I have established a proven track record of success, which highlights my unwavering commitment to professionalism, high work standards, and adherence to the strictest quality and regulatory guidelines.
Overview
12
12
years of professional experience
1
1
Certification
1
1
Language
Work History
Scientist - Process Development
Dr.Reddys Laboratories Ltd.
Hyderabad
03.2022 - Current
- Utilize and Apply knowledge of basic scientific principles, theories and concepts to develop solutions to resolve day to day process related problems, Design and conduct experiments at small and medium scales in co-ordination with R & D group.
- Remediation of Various issues related to commercialized product by Identifying problem statement, development of hypothesis, perform experiments to establish root cause for the problem and hypothesis developed followed by solution implementation at site and finally complete the remediation by execution of product and providing justification for variation filing as per SUPAC.
- Collect and analyze data from development batches, Trends data for various process parameters and quality attributes from APQRs to provide technical inputs on various issues related to product remediation, Master formula card (MFC) and Technology transfer (TT) documents, Perform risk assessment and present ideas for modifying existing procedures and suggest alternative methods to improve results
- Responsible for all activities involved in the scale-up from pilot to commercial scale and process development of products transferred from other manufacturing sites for oral dosage forms.
- Coordinate timelines and negotiates resource management with other departments for scheduling of the work to ensure timely completion of the scale-up/tech transfer projects
- Planning, Execution and Monitoring of Feasibility / Exhibit / Pre-validation / Process Qualification batches for technology transfer of new products and site transfer products.
- Arrangement for phase gate discussion with CFTs before Process Optimization, pre-validation, post validation stages to finalize recommendations on observations & results.
- Calculation and finalization of batch size for Trial batches, Process Optimization batches, exhibit batches & for commercial batches based on the scientific scale up techniques. i. e. Tip Speed calculation, Occupancy calculation, Trouble shooting and addressing the issues arise during trail batches & scale up.
- Co-ordination with FR&D, AR&D, Quality Control, Quality Assurance, PPIC, Regulatory Affairs ,Supply chain management team and other CFT's to meet timeline as per requirements.
- To prepare product process related protocols, Checklists and reports for feasibility trials, scale up batches and Review of documents like BMR, BPR, PVP, PVR, HTSP, and HTSR. Preparation of response to regulatory agencies query relevant to process and technology transfer.
- Timely support for Initiation, follow up and closure of quality compliance documents like Change Control, Deviation. Responsible to perform/review the investigations arising from incidents, out of specifications, out of trends to identify the root cause for betterment of Product Quality.
- Review of Tooling drawings, change parts and provide technical support to production department for commercial launch of new product .
- Preparation and approval of Standard Operating procedure and Ensuring sharing of knowledge and explaining department practices to the new employees in the department.
- Efficiently transfer the technology for soft gelatin capsules by monitoring and controlling CPP at Medicament Preparation, Gelatin preparation, Encapsulation, Drying, Sorting, and Polishing & Printing stage.
- I have effectively resolved various quality issues related to commercialized product by modifying existing procedures and adhering to SUPAC guidelines. This achievement has led to improved product quality.
- Through my efforts to reduce rejections at different stages of product manufacturing, I have been able to increase the yield of finished products significantly. This has had a positive impact on the company's profitability and overall efficiency.
- By modifying unit operation parameters, I have successfully reduced the operation time for product manufacturing, resulting in significant cost savings for the company in terms of time, utility, manpower, and finances. This experience has taught me the importance of continuous improvement
Senior Executive - Technology Transfer
Aurobindo Pharma Ltd.
Hyderabad
02.2020 - 03.2022
- Execution & monitoring of process development and process optimization of formulation batches for Tablets, Hard gelatin & Soft Gelatin Capsules, Oncology Products for regulated markets [EU & USA ].
- Responsible for Preparation of Manufacturing Documents like, Master production control record, Batch production control record, Process validation protocol, Process validation report, Hold time study protocol and Report based on Technology transfer documents.
- Preparation of Proposed Commercial MPCR based on marketing requirement. Preparation of Standard operation procedures and ensuring the compliance as per requirement.
- To review and provide technical inputs on product development report (PDR), Master formula card (MFC) and Technology transfer (TT) documents etc.
- To Support Process Validation (PV) batches and provide technical inputs in process validation documents such as Critical Process Parameters (CPPs), Critical Quality Attributes (CQA) and controls.
- Timely support for Initiation, follow up and closure of quality compliance documents like Change Control, Deviation, and Investigation Reports for betterment of Product Quality.
- Provide technical input for the documentation and execution of Scale up, trial batches, submission and commercial launch/validation batches for ANDA and site transfer products
Senior Research Associate - Process Development
Intas Pharmaceutical Ltd.
Ahmedabad
08.2018 - 02.2020
Senior Executive
Micro Labs Ltd.
Goa
10.2014 - 08.2018
Officer - Quality Assurance
Marksans Pharma Ltd.
Goa
12.2013 - 10.2014
Quality Assurance Officer
MDC Pharmaceutical Pvt. Ltd.
Baddi
07.2011 - 07.2013
Education
Master of Pharmacy - Pharmaceutical Biotechnology
Rajiv Gandhi Proudyogiki Vishwavidyalaya
Bhopal 06.2009 - 2011.06
Bachelors of Pharmacy - Pharmaceutical Sciences
Jiwaji University
Gwalior 07.2005 - 2009.06
Higher Secondary -
Convent Higher Secondary School
Morena 03.2000 - 2001.04
High School Diploma -
Convent Higher Secondary School
Morena 03.1998 - 1999.03
Skills
Process Development and Process Validation
Accomplishments
- Received “ Award for Excellence in R&D” at Dr. Read's Laboratories Ltd. for trouble shooting of quality related issues issues in commercial products within the given timeline and making a significant contribution to the organization.
- Received “Talent of the month” Certificate of Appreciation for the month of August-2020 at Aurobindo Pharma Ltd. For delivering the project on time by taking responsibilities for the project and showing leadership quality.
- Completed courses and Received Digital Ninja 3.0 Certificate by Dr. Reddys Laboratories Ltd . to digitally up skill in the domain of Digital, Data and Design & taking a step ahead towards digital transformation journey.
- Qualified GATE-2012 organized by IIT Delhi on behalf of National Coordination Board, Department of Higher education, Ministry of Human Resource development , government of India, with ALL INDIA RANK 452 (98.97 percentile).
Additional Information
Granulation: RMG (Glatt, Chitra, Sainath), FBE (PAM GLATT, GEA, Gansons), Hot Melt Extruder (Thermo scientific), Extruder spheronizer (Umang).
Compression: Sejong HRC, Korsch XL400FT 29 stn, Kembert KX100 8 stn., Fette P3030 30 stn, Karnavati 26 stn. Cadmach CTXIII A, Fabtech Isolator/GEA Performa P 24 stn (for MUPS)/Killian Romaco, Dr.Pharma
Coating: Sejong SFC 100 FS, Neocota, GPCG 1.1, GFB Lab,Wruster Coater (GFB PRO 30)/GlattGCSi,Gansons
Encapsulation: AF25T, AF40T, AF90T, AF150T, Anritsu Checkweigher KW9002AP, Accura 40, Zanasi 70C
Soft Gelatin Capsules: Gelatin Preparation Vessel (100 & 200 Ltr.) , Medicament Preparation Vessel (20 & 200 Ltr.),Color mixing head (SCMX-500),Encapsulation machine GKF 72 ( ACG Pam) & SV 3000(Sky softgel), Autosorting machine(Sky softgel), Gansons Polishing Pan 42”, Laser Printing machine SLP 100 (Sky soft gel) and Ink Printing machine PPT-32I(Parle Elizabeth).
Project Handled
Tablets : Single Layer/Bi-Layer/Tri- Layer Tablets (Immediate and Modified Release)
Soft Gelatin Capsules: Steroidal, Vitamin-D Derivatives, NSAIDS, Anticancer, Anti Allergic Formulations
Hard Gelatin Capsules: Blend in Capsule, Pellets in Capsule, Tablets in Capsule, Blend & Tablets in Capsule
Pellets: Coating (Wurster Coater), Compression (GEA Compression for MUPS), Extrusion & Spheronization
Software
Interpersonal Skills
- Demonstrate adherence to company policies/procedures, regulatory compliance & quality requirements.
- Strong technical writing skills & Communication skills.
- A self-starter, work proactively with a can-do attitude.
- Expertise with multiple formulation forms.
- Strong team player with good interpersonal and organizational skills.
- Solution oriented and able to deliver results within a limited timeline.
Regulatory Audit Faced
USFDA, MHRA, ANVISA, TGA, MCC, HEALTH CANADA and various internal & customer's audit.
Certification
Registered Pharmacist by Madhya Pradesh State Pharmacy council
Personal Details
Gender : Male
Nationality : Indian
Marital status : Married
Passport No. : Z3716267
Timeline
Scientist - Process Development
Dr.Reddys Laboratories Ltd.
03.2022 - Current
Senior Executive - Technology Transfer
Aurobindo Pharma Ltd.
02.2020 - 03.2022
Senior Research Associate - Process Development
Intas Pharmaceutical Ltd.
08.2018 - 02.2020
Senior Executive
Micro Labs Ltd.
10.2014 - 08.2018
Officer - Quality Assurance
Marksans Pharma Ltd.
12.2013 - 10.2014
Registered Pharmacist by Madhya Pradesh State Pharmacy council
01-2012
Quality Assurance Officer
MDC Pharmaceutical Pvt. Ltd.
07.2011 - 07.2013
Master of Pharmacy - Pharmaceutical Biotechnology
Rajiv Gandhi Proudyogiki Vishwavidyalaya
06.2009 - 2011.06
Bachelors of Pharmacy - Pharmaceutical Sciences
Jiwaji University
07.2005 - 2009.06
Higher Secondary -
Convent Higher Secondary School
03.2000 - 2001.04
High School Diploma -
Convent Higher Secondary School
03.1998 - 1999.03