Shambhu Seth
Baddi
Summary
I am pharmacy graduate having an experience of 19.0 years in formulation tech transfer/Oprationals of solid dosage formulations.I am very much interested to pursue my carrier in your esteemed organization. I came to know from a reliable source that there exists a vacancy Target oriented, cost optimization, regulatory compliance A result-oriented professional, with strong planning, communication, interpersonal & negotiation skills, aspiring an assignment in a growth oriented organization of repute to utilize acquired skill & knowledge in contributing to organizational goals while attaining personal and professional goals.
Overview
20
20
years of professional experience
Work History
TORRENTPHARMA,LTD
01.2015 - Current
- Effective planning, scheduling, budgeting, prioritizations and integrating to enable successful timely delivery of projects deliverables to meet Organization milestones
- Handled Global projects (SPOC) along with timeline, tracking key milestones, proactive planning, on time delivery and cost effectiveness
- Follow up for timely arrangement of RM and PM procurement and its analysis & release for execution of batches
- Effective coordination and follow up with operation team for seamless execution of the projects and ensure the target completion date for different regulatory filings and launches
- Proactively identify the potential risks and their analysis that enabled the teams to identify the trigger and resolve or mitigate the risks proactively to meet the project deliverables
- Keep updating all the projects status time to time and share the status with cross functional teams
- Scheduling and managing the meetings to ensure continuous engagement of internal and external stakeholders
- Coordinate with finance team to ensure the cost implications and CAPEX approvals
- Identify and closely monitoring of critical path activities to ensure the project is on-track
- Conduct periodic reviews with team leads for project tracking with internal & external partners
- Proficient in developing & streamlining systems with proven skills to enhance operational effectiveness and meet operational goals within cost, time & quality parameters
- Develops, maintains and provides process expertise in order to deliver knowledge transfer to cross- functional operational and technical areas for skill development
- Involve for product robustness and process improvement
- Perform gap analysis (technical) and provide technical support for site transfers/ new launch products
- Work effectively at the interface with other domains/departments to achieve the end goal
- Production batch execution planning with manufacturing team on regular basis
- To handle trouble shooting during exhibit and commercial batches with an ability to investigate any Out of Specification (OOS) or Out of Trend (OOT) results
- Practical exposure to work in formulation solid oral dosage forms like tablets, capsules and Topical and Oral liquid formulations
- To execute, manufacturing and practical exposure to work in various tablets formulations like immediate release, modified release, bi-layer formulations, hot melt extrusion formulations
- Good knowledge and operating skills of different technologies such as Hot melt extrusion, Granulation using Top spray and RMG, Extruder, Spheronizer, Pellets Coating, Compression, Coating and encapsulations
- Decision of batch size in coordination with F&D and manufacturing department
- FDA approval on Tablet/capsule/Liquid/External Preparation
- CGMP training getting by Dr
- Roland from WHO Geneva
- Application of PAT tools
- (NIR
- SCADA, Torque, AWC)
- Audit Exposure
- USFDA
- EUGMP
- NVISA Brazil
- MHRA
- SERBIA MOH
- WHO Geneva
- TURKEY MOH
- Kazakstan MOH
- UGANDA and KENEYA MOH
- UKRAIN
- Customer audits for export(Roche/Grunenthal/Merck/GSK/BAYER/PFIZER/BLEUFISH)
ALKEM LABS,LTD
11.2013 - 12.2014
PANACEABIOTEC,LTD
07.2010 - 11.2013
NICHOLAS PIRAMAL INDIA LTD.
12.2007 - 06.2010
CIPLA. LTD
06.2005 - 12.2007
Education
GED - Pharmacy
06.2005
Skills
- Strong Planning, Communication, Interpersonal & Negotiation Skills
- Team player
- Learning attitude and punctuality
- Ability to multi task and prioritize responsibilities
- Continuous smart & dedicated work
- Understanding towards responsibility
- Team leadership and motivation
- Administrative support
- Leadership
Additional Information
FDA approval on Tablet/capsule/Liquid/External Preparation, cGMP training getting by Dr. Roland from WHO Geneva, Application of PAT tools. (NIR. SCADA, Torque, AWC), Audit Exposure: USFDA, EUGMP, NVISA Brazil, MHRA, SERBIA MOH, WHO Geneva, TURKEY MOH, Kazakstan MOH, UGANDA and KENEYA MOH, UKRAIN, Customer audits for export (Roche/Grunenthal/Merck/GSK/BAYER/PFIZER/BLEUFISH)
Timeline
TORRENTPHARMA,LTD
01.2015 - Current
ALKEM LABS,LTD
11.2013 - 12.2014
PANACEABIOTEC,LTD
07.2010 - 11.2013
NICHOLAS PIRAMAL INDIA LTD.
12.2007 - 06.2010
CIPLA. LTD
06.2005 - 12.2007
GED - Pharmacy
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