GANESH VALLAKATI

• Seeking career enrichment in Pharmaceutical Production and Packaging management domain with a frontline organization and empower my technical knowledge and skill in the same.
• Production Planning.
• Process Improvement.
• Documentation.
• Well-versed in various concepts relating to injectable visual inspection and packaging.
• Over 18 years of experience in visual inspections and packing operations (mainly injectable SVPs, such as contrast media, terminally sterilized products, lyophilized products, dry powders, and vaccine formulations, as well as LVPs, including contrast media) in the pharma sector.
• Good, comprehensive exposure in planning and organizing day-to-day formulation and packing activities. Adopt and implement quality systems in coordination with cross-functional departments. Capable of resource planning and development for ensuring seamless production operations.

• English
• Hindi
• Telugu

Preparations and reviews of SOPs and BPRs

QMS activities, like CAPA, change controls, and deviations

Involved in the batch visual inspection and packing activities, led the assigned optical testing line/area, and packing area

Ensure the optical, visual inspection line clearance, and handling manpower

Receiving production for optical inspection of vials, ampoules, and PFS lyophilized vials, checking total units

Responsible for the maintenance of the visual inspection qualification kit, identification, and preparation of the visual inspection list

Responsible for the verification of defective vials after the visual inspection of operators

Responsible for imparting training to newly identified inspectors, responsible for the preparation of records and observations

Involved in labeling, packing line activities, and maintaining online BPAR documents

Track and Trace (Jekson Vision) - Creation of master products, transferring batches in line systems, and verifying serialized codes

BPO (Barcode, Pharma code, OCR, Data matrix, Flapper Base, Logo Inspection system)

Accurately and timely complete in-process checks, along with BPARs, and all other key documents

Maximize shift productivity by proactive prioritization of activities

Handling of balances and ensuring their timely calibration

Maintenance, good housekeeping, in the visual inspection and packing work area

Handling the new injectable packing line project, coordinating internal resources, and third parties/vendors for the flawless execution of the project, and creating and maintaining comprehensive project documentation

Responsible for follow-ups and achieving monthly targets of injectables

Control on manpower and machine utilization to maintain and improve productivity in the department

Motivating downline team members for better productivity by creating a healthy work atmosphere

Successfully fulfilling assignments given by the HOD

Provide training to team members in maintaining compliance with the SOPs and technical directions

Follow and implement the cGMP and GDP to meet the regulatory requirement

Online documentation of BPPR, monitoring of cGMP records, yield declaration, and reconciliation after completion of the batch, and submission to the QA department

Handling of the new vial line project involved the review of protocols and the execution of the qualification of all packing equipment and instruments

Implementing a quality procedure (SOP) and system to facilitate the smooth functioning of packing operations, and enhancing operational efficiency