Manager Analytical R&D and Quality Control
AVALON PHARMA
Total years of experience :20 years, 1 Months
Managing a team of 25 sub-ordinates
Ensuring products meet quality and efficiency standards together with technical and scientific support for the organization
Spearheading Analytical Team for successful development, validation, stability studies, troubleshooting, New Product selections support and Quality Control for different markets so on for products (solid, liquids, suspensions, creams and so on)
Focusing on the progress of analytical development groups/projects and other involved technical integrator functions
Confirming high quality in technical reports and regulatory documentation
Resolving analytical project challenges during the phase of product life cycle during product development and commercial manufacturing; coordinating with inter teams and inter departments and providing high-value and proactive touch points throughout the product development life cycle and continuous improvement in Quality control lab processes
Prepare complete quality module documents required for the new products registration in SFDA/GCC and other middle east and African markets
Participate and involve in the Business development procedure for product selection, feasibility and execution
Assessing and ensuring quality controls, inspection and testing activities of high productivity and high technical integrity for the finished product, raw material and packaging materials
Identifying & rectifying the product related problems in the already registered commercial products and variations for smooth manufacturing; managing departmental activities on Chemical and Microbial Testing of RM, FG, PM related to tablets, liquids, ointments, creams and so on for the routine production and research activities
Monitoring lab investigations w.r.t. deviations, CAPAs, managing change control, OOT and OOS data in a timely manner and adhering to SOPs and protocols; ensuring that good lab/documentation practices are there pertaining necessarily for product quality testing and calibration standards
Reviewing protocols & reports for analytical method transfers, validations and all related quality control studies plus qualification and routine calibration of analytical instruments
Adhering to the SFDA/ ICH / EMA norms, meeting the regulatory audits & compliance requirements
Supporting for the CTD Dossier preparation and regulatory queries resolutions; implementing procedures related to Quality Management Systems (QMS) and also monitoring performance of those systems
Conducting stability testing and documentation for maintaining standard objectives
Addressing compliance and GAPs identified during Gap assessments & regulatory audits
Co-ordinating the purchase of laboratory equipment, services and chemicals from reputable suppliers/laboratories etc
working as an Assistant Manager, Analytical Development in Riyadh Pharmaceuticals, Riyadh - Saudi Arabia.
• Responsible to Manage and Lead Analytical Development, Validation and stability activities formulation products of solid dosages, Liquid orals/drops, Nasal Sprays etc.
• Handling Projects pertaining to Abbott, Janssen-Cilaag, Norgine, Pharma MNC’s for the complete product development and optimization.
• Provide trouble-shooting expertise and implement actions. Recommend changes to methods or operations as appropriate
• Provide high-value, proactive touch points throughout the product development life cycle
• Prepare client-ready presentation materials for business development
• Collaborate with interdepartmental heads across all disciplines to coordinate resources in order to accomplish the Project success
• Approval of STP’s, SOP’s, Protocols for experiments and other lab operations
• Train and provide technical expertise to less experienced staff.
• Handle and Respond to the Regulatory Queries
• Involved in the decision and purchase of laboratory instruments & equipments.
• Approval of the qualification of Analytical instruments
• Implementation of cGLP & cGDP in lab
developing Industrial chemicals, Performance chemicals, Pharmaceutical and life science chemicals.
Key work involves:
Development and validation of analytical methods of various formulations.
Carrying out routine & stability analysis on the IR/NDDS pharmaceutical formulation products.
Wet analysis of various excipients and API for qualification.
Calibration and maintenance of instruments in the analytical lab.
GLP compliance by adhering to the GLP norms.
Method transfer to the manufacturing location.
Instruments handled
HPLC, GC, UV, IR, DSC, Conductometry, Potentiometry, Ph-metery, Centrifuges, Auto titers, Particle size analyzers, Karl fisher titers.
Projects undertaken
“ Stability testing of Some Pharmaceutical Products” from ATS
(Analytical Testing Service) a division of Ranbaxy Pharmaceuticals
Presently Research Associate in JUBILANT ORGANOSYS LTD.
New Delhi, a Research & Development Co., developing Industrial chemicals, Performance chemicals, Pharmaceutical and life science chemicals.
Key work involves:
Development and validation of analytical methods of various formulations.
Carrying out routine & stability analysis on the IR/NDDS pharmaceutical formulation products.
Wet analysis of various excipients and API for qualification.
Calibration and maintenance of instruments in the analytical lab.
GLP compliance by adhering to the GLP norms.
Method transfer to the manufacturing location.
Instruments handled
HPLC, GC, UV, IR, DSC, Conductometry, Potentiometry, Ph-metery, Centrifuges, Auto titers, Particle size analyzers, Karl fisher titers.
Projects undertaken
“ Stability testing of Some Pharmaceutical Products” from ATS
(Analytical Testing Service) a division of Ranbaxy Pharmaceuticals
Winner of UNIVERSITY GOLD MEDAL for standing 1st. in M.Sc Recipient of Manoj Varshney Scholarship (for topping in Masters.) Recipient of HakeemAbdulHamid Scholarship (for outstanding performance) Awarded Certificate for Excellent performance in Graduation Awarded Certificate of Excellence in Physics Olympiad during 12th S.Sc Specialization during Masters • Petroleum and Agrochemicals • Stereochemistry &Reaction Mechanism And Molecular rearrangement • Natural Products • Polymer Chemistry • Thermodynamics • Analytical Chemistry Analytical Techniques known • Spectroscopic Techniques (NMR, IR, UV-Visible, Mass, Atomic absorption /emission • Chromatography Techniques (GC, HPLC, IEC, IPC, TLC) • Centrifugation Techniques • Electrophoresis Techniques • Conductometry, Potentiometry • DSC Computer Literacy Proficient with Window OS, MS-Office Applications, ChemSoft Application Software, Chromatographic software, C and C++
Awarded Certificate for Excellent performance in Graduation Awarded Certificate of Excellence in Physics Olympiad during 12th S.Sc