V Ananth

To build a career conductive to professional and personal growth and to gain practical experience in meeting the challenges of hi-tech environment with committed & dedicated people and to work as a key player in challenging & creative environment. Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.

Friendly Deputy Manager committed to creating a positive work environment through effective mentoring and coaching. Skilled in delegation and communication. Talented in leadership, staff development and training. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.

• Executing/ Reviewing the HVAC validation for the manufacturing facility for the different classification.
• Qualifying the compressed air in the facility.
• Cleaning validation activity, identifying the worst-case molecule, identifying the MACO value by preparing the matrix with PDE, LD50 and TDD results.
• Carrying out the Cleaning validation with respect to allergen.
• Coordinating/ executing/ reviewing the URS, FAT documents, installation, operational and performance qualification.
• Carrying out the process validation.
• Executing/ Reviewing qualification of the equipment like blister packing machine, auto cartonater, compression machine, encapsulation machine, etc.
• Reviewing the computer system validation documents like ERP validation, PLC validation to ensure the requirement of GAMP 5 and 21 CFR part 11 compliance.
• Preparing, and executing the excel (spreadsheet) validation.
• Automate the excel with protection having various formulas like APQR, MACO calculation sheets
• Supervising and ensuring effective functioning of quality system.
• Supervising and ensuring the better control system.
• Providing support for process validation and cleaning validation.
• Qualifying the external service provider for executing the calibration, HVAC validation and compressed air qualification.
• Good knowledge in handling MS word, MS Excel and MS power point, especially in MS excel for automating excel sheets like APQR, and complex formulas like MKT.

• Performing Validation activities like HVAC validation, process simulation, SIP, SHS, DHS validation activities and reviewing of the validation documents.
• Reviewing of Validation protocols and reports for Sterilization In place (SIP) of equipment, Steam Heat Sterilizer (SHS), Dry Heat Sterilizer (DHS), HVAC system, Laminar Air Flow system, Restricted Access Barrier System and smoke study.
• Reviewing of BMR/BPR, Cleaning Records Related to manufacturing facility.
• Preparing and reviewing of Process validation protocols and reports, Clean room validation protocols and reports.
• Performing self-inspection audit, and undergo daily rounds to API manufacturing facility and Stores.
• Reviewing of protocols and reports for Process simulation study.
• Reviewing of calibration certificates from external agency.
• Reviewing of system generated printouts from the manufacturing facility.
• Handling Quality Management System.
• Reviewing, investigating and preparing the market complaints and reviewing the Corrective and Preventive Action.
• Preparing and reviewing of SOP’s.
• Providing compliance to the audit points.
• Monitoring of cGMP and spelling with colleagues.
• Follow up the documents until get closed from the user end.
• Having good knowledge preparing reports, handling and preparing tracking reports in excel.
• Well trained to work in control environment and operating aseptic processing.
• Maintaining cGMP, and documentation.

• US-FDA
• MHRA
• WHO-GMP
• TGA
• EU-GMP
• COFEPRIS-MEXICO
• INTERNAL AUDITS

• Experienced to handle MS office (word, excel and power point).
• Computer literacy programming (CLP).

V. Veeraiya

• Date of Birth: 05/29/84
• Gender: Male
• Nationality: Indian

• Achieved quality output and simplified through effectively helping with automating the excel sheet for product quality review. Saved the 200 man days.
• Used Microsoft Excel to develop inventory tracking spreadsheets.
• Collaborated with team in the development of Artwork, product quality review.
• Developed tracking system for work completion tracking.