Shimla, Himachal Pradesh, India
Common Sense, Advertising, Documentation
About
A young and energetic MBA with specialization in marketing and strong grasp of marketing concepts.. With proven abilities in building and nurturing relationships coupled with excellent communication skills I am confident to establish my professional credibility in business assignments. My rich exposure of fourteen years in production of pharmaceutical API strongly supplements my education to realize my cherished aspirations to build a career in business assignments.

Talents
Work Experience
Executive, Production
Full Time Mar-2000 To present 25 years 1 month
Responsibilities
  • Contributed 14 years in production of pharmaceutical API (Bulk Drug) with strong understanding of consumption norms of raw ingredients.

    • Handled finished goods powder processing maintaining the required atmosphere - positive pressure, humidity control, temperature control etc according to cGMP specifications.

    • Co-ordinated with quality control deptt, QA deptt, planning deptt & warehouse deptt. to ensure adherence to quality parameters & reviewing of batch production records.

    • Maintained appropriate various FDA documentation- Blending record, FG transfer record, quality data record, PP-rooms cleaning record, AHU records etc.

    • Regularly achieved production milestones with strong commitment to work assignments.

    • Encouraged seamless communications amongst team members and generated excellent work harmony for better efficiency.







    • Documentation Qualification: Installation Qualification, Operational Qualification, Performance Qualification of equipments like Reactor- SS & MSGL both, Rotary Vacuum Dryer, Sparkler Filter, Tray Dryer, Vacuum Tray Dryer, Agitated Nutsche Filter etc protocol & report preparations and exhibit batch protocols.

    • Documentation Validations: Process performance qualification, Drying process validation, Blending time validation, Prospective process validation, Concurrent process validations: Protocol & reports preparations.

    • Handled FDA audits USA, TGA audits Australia, WHO Health organization audits, EU audits, CQA audits, MCA UK audits.

    • Develop, implement and maintain procedures to ensure that products are produced within specification: Change controls implementations & closures in TRACKWISE software.

    • Assist in ensuring Product Integrity and Traceability processes are robust, reviewed and maintained. Ensuring that all product specifications are aligned with process capabilities.

    • Process Control: controlling critical process parameter to achieve better yield and quality.

    • Strong Chemical Process handling working with strong commitment with very high caliber.

    • Strong grasp of Knowledge of in-process testing like pH checking, Determining Moisture content handling instrument make of METROHM , Strength of HCl, NH3, NaOH etc

    • Strong grasp of making Investigation Report if the batch is failure & CAPA Investigations.

    • Maintain ISO documents like environment management system, aspect & impact evaluation etc.

    • Making Deviation Report on the basis of FDA guidelines. Whether the deviation is planned or unplanned.

    • Raw Material procurement and reconciliation with stock in SAP system.

    • Downloading the data from SAP system having strong grasp knowledge of using SAP system with very high caliber.

    • Excellent planning, organizational and project management skills.

    • Creative, energetic and willing to implement new ideas.

    • Demonstrated positive trends in key quality management process measures (rework, deviations, complaint, CAPA management) – Expert in operating Track wise software.

    • Expert i
Achievements
  • Product Management.
Education
Bachelor of Science, Marketing
Shri Vishnu S D P G CollegeHimachal Pradesh University
1994-1997
Medical Technology
1994-2010 Score57%
Bachelor of Science in Physics, Medical Technology
, HPU, Shimla, HP.
1994-2010 Score57%
Extra-Curricular Interests
  • Management ideas

  • Carrom

  • Cricket

  • Table Tennis

  • Chess

  • Listening New Hindi film songs and Bhakti songs

Profile Snapshot
Anil is based out of Shimla & has studied Marketing, B.Sc-Bachelor of Science from Year 1994-1997 in SVSDPGC-Shri Vishnu S D P G College, Himachal Pradesh University.
Anil Tiwari is Skilled in Common Sense, Advertising, Documentation and other talents.