COMPANY EXPERIENCE


Wockhardt Pharmaceutical

Aurangabad, India

Assessment, Approval and Implementation of the visual inspection kits including the following:

  • * Visual Inspection Defect Categorization and Classification for Syringes, Vials and Cartridges
  • * Visual Inspection Kits creation for syringes and vials (clear liquid and suspensions).

Intas Pharmaceutical

Ahmedabad, India

Assessment, Approval and Implementation of the entire visual inspection program including the following:

  • * Visual Inspection Defect Categorization and Classification for Syringes, Vials and Cartridges
  • * Visual Inspection Kits creation for syringes and vials
  • * Generation, Approval and Implementation of procedures and visual inspection technique.
  • * Inspection Kits Generation and Certification
  • * Training and Certification to Visual Inspectors
  • * Visual Inspection Batch Record
  • * Support to Packaging and Inspection Deviations

Assessment and Improvement of the manual packaging lines covering the following:

  • * Evaluation, improvement, approval and implementation of batch record
  • * Planning and Organization
  • * Segregation of Areas increasing output in 50%.
  • * Improvement and measures of quality on the floor
  • * Training and Certification

Intervet Schering Plough

Estado de Mexico, Mexico
  • * Assessment, Implementation and Certification phases for the Quality Remediation Project of Inactivated Antigens - bulk product. The EMEA certification was granted after project termination.
  • * Positions involved: Project Manager, Engineers, Quality Assurance and QCL Specialists.

Amgen Manufacturing Limited

Juncos, Puerto Rico

Technical Support to the day to day filling and packaging operation resolving technical issues during the operation. The support provided includes: Inspection

  • * Vials and syringes cosmetic defect evaluation and Inspectors Certification.
  • * Creation of challenge kit for inspection machine challenge.
  • * Technical Protocols for process improvement for visual and automatic inspection.
  • * Evaluation of defects including forensic analysis to determine product impact and implement CAPAs.
  • * Creation of visual inspection kits, defective units for automatic inspection validation protocols, inspectors certification.
  • * Vials and syringes cosmetic defect evaluation.
  • * Visual Inspection Program Creation, Training and Certification of Parenteral Syringe and Vials Inspectors.
  • * Creation of training defect panels for inspectors certification.
  • * Technical Protocols development and execution for validation of inspection process.
  • * Evaluation of defects including forensic analysis to determine product impact.
  • * Parenteral Inspection Process Procedures Generation and Approval

ABBVie Biotechnology Operations

Barceloneta, Puerto Rico
  • * Creation of Automatic Inspection Standards and Assessment
  • * Consultancy on Automatic Inspection Approach and the last update on PDA.

Intas Pharmaceuticals

Ahmedabad, India
  • * Visual Inspection Program Creation including Procedures, Inspection Technique and Batch Record.
  • * Visual Inspection Kits Generation for all presentations
  • * Remediation of Packaging and Inspection Areas for Improvement on FDA Regulation

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