Veerraghavulu P

Handling of Change controls.

Handling of Deviations through Track wise application

Preparation of MFR and Batch records.

Preparation of Protocols and Record of results.

Preparation of Media fill reports.

Internal Audit.

Review and approval of executed documents.

• Documented deviations in procedures or appearance on production batch sheets for management review.
• Monitored production line for unsafe behaviors or incorrect techniques and worked with managers to resolve problems.
• Assisted with maintaining good manufacturing practices on [Type] production line.
• Fabricated and assembled products based on customers' specifications.

• Involved in the green field project for the Jennsen Covid-19 vaccination.
• Equipment qualifications and Media fill simulation studies.
• Preparation of Study protocols and Record of results for the Media simulations and other process related qualifications.
• Preparation of media fill study reports and other qualification reports.
• Incorporation and qualification of Single use systems for the online filtration and Filling process.
• Preparation of SOP as per the process requirements.
• Preparation of Manufacturing BPR.
• BPR reconciliation and review.
• As training coordinator and Course administrator, revisions of SOP in the LMS, and making the effective the SOP in the online system by providing the training.
• Providing practical training to the newly joined employees on the respective equipment's.
• Execution of batch activities as per the plan and reporting of deviations if any abnormalities observed during the execution.
• Execution of Air flow simulation studies.
• Preparation and evaluation of interventions trends and based on the trend reports defining the maximum frequency for the interventions for the commercial batches.
• Initiation, review and timely closure of QMS elements like Change control, deviations and CAPA.
• Front line SME for the USFDA audit.

• Maintaining all documents related to Production Areas as per cGMP.
• To ensure immediate information to superiors in case any anomalies found in the process.
• Planning and execution of batch manufacturing activities.
• Batch Reconciliation at various stages.
• Preparation of BPR.
• Preparation of Sop as per the process requirements.
• Preparation of Monthly, Quarterly and Annual trends of critical equipment alarms.
• Initiation, review and timely closure of all QMS elements like Change control, Process Non-Conformances and CAPA.
• To ensure the online completion of batch records and logbooks at various manufacturing stages.
• Updating cGMP related practices, such as Kaizen, and recent regulatory upgradation to the personnel working in the shop floor to improve the systems.
• Co-ordination with training team and ensure the completion of training of all the production personnel working in respective areas.
• Following safety systems and GMP systems during the work execution.
• Preparation of quarterly trends for planned batch activity viz., Online NVPC system, Interventions, offline NVPC system & CCTV system.