Satish Kumar Ragoonathan

• To plan day to day shift activities in coordination with the superior to and planning in order to achieve production requirements.
• Prepare/review/train SOP and EOPs related to operations.
• To ensure that all production activities are carried out in compliance with the cGMP requirements by strictly adhering to the standard operating procedures and good documentation practices.
• Ensures all team members strictly comply with cGMP procedures.
• Adherence to safety, health, hygiene and environmental measures
• Follow dedicated procedures to enter Drug Product building
• Follow dedicated procedures to enter Clean-room area of Drug Product building as per procedures 
• Follow dedicated behaviors and hygiene as required in clean-room area as per procedures.
• Ensures all team members are properly trained before assigning tasks.
• Strictly implements line clearance procedure. Escalates any issue immediately to superior.
• Ensure that the following activities are performed as per Standard Operating 10. To carry out Procedures.
• To carry out and ensure that the equipment are operated as per Equipment Operating Procedures.
• To carry out Ensure the correctness and accuracy of the data to all the batch records, status labels, checklist,logbooks and other document related to manufacturing activities.
• Periodically review the log books to ensure that good documentation practices are followed.
• Ensure documentation and logbooks are properly maintained to the operation area
• Periodically review the SOPs points to ensure that the SOPs reflect current practice. Periodically review Batch Manufacturing Record (BMR) and Batch Packing Report (BPR) to ensure that the BMR and BPR reflect current practice. Support qualification and validation of equipment and process.
• Supports the Preventive Maintenance and Calibration of Equipment and Instrument to be within
• Due date in coordination with EM and IA Instructs and ensures all team members in the proper use of required PPE.
• Addresses and corrects with audit observations with respect to manufacturing activities.
• Responsible for manpower management by allocating defined responsibilities to the team members.
• Responsible for BM QA SOP 025 Good Distribution Practices for Medical Device (GDPMD) and ISO 13485 compliance in daily activities
• To record and maintain daily reports. Identifies and generates deviations, change control and other related documents in coordination with QA
• Coordinates with other departments such as QA, QC, Warehouse, EM and LA to achieve day to day production requirements.
• Conducts training and coaching of newly hired employees
• Carry out related tasks as assigned.
• Contributes in handling the problems related to equipment in co-ordination with EM and IA
• Ensures all production activities comply with all Biocon corporate quality and safety standards and local regulatory requirements as per cGMP and EHS, which includes but not limited to: Proper work attire and personal hygiene.
• Cleaning and sanitation of work area and equipment Maintenance of product integrity.
• Raising Maintenance Requisition Form regarding problems and handling the concerns in a correct and proper manner.

• -Will ensure and maintain the stability of processes, high quality standards and optimized
  throughputs for the machines at all time.
  -Support the processes during production build as well as to develop/assist in developing
  new specific processes for new package introduction.
  -Initiate cost reduction projects, productivity and yield improvement projects.
  -Design and modify tooling, equipment or machinery for higher performance and
  efficiency.
  -Generate and maintain process and equipment specifications as well as to provide training
  to operators and supervisor in specific processes.
  -Plan and managed daily engineering runs and management of the yield, cycle time and
  report writing.
  -Direct requirements.
  -Front to end assembly process.
  -Analyze process and machines performance including trouble shooting support, technical
  requirement with close partnership of other functional teams to drive through product.
  -Improve process capability and production volume while maintaining and improving quality
  standards. Prepare samples for study.
  -Provide suggestions during incident investigations and advise on corrective actions.
  -Designing new equipment, processes, procedures and systems
  -Purchasing and installing equipment
  -Repairing equipment
  -Responding to breakdowns
  -Investigating production problems
  -Making improvements to current operations to enhance efficiency
  -Supervising engineering and technical staff
  -Managing budgets
  -Diagnosing faults
  -Planning and organizing maintenance
  -Liaising with suppliers, customers and research and development staff.
  -Managing and follow up machine tooling, common and NPI projects spare parts.
• (Working on the new plant setup in Penang Batu Kawan, April 2021‑Dec 2022)
  -Plant layout is the arrangement of machines, work areas and service areas within a factory.
  -Plant layout involves the development of physical relationship among building, equipment and
  production operations, which will enable the manufacturing process to be carried on
  efficiently.
  -Plant layout is a plan of an optimum arrangement of facilities including personnel,
  operating equipment, storage space, material handling equipment and all other supporting
  services along with the design of best structure to contain all these facilities.
  -Working with HR on the site manpower preparations which is for TS ,Engineer hiring
  process.
  -Working with the Project Associate Engineer admin on the ordering office and engineering
  tools and following up on the orders status and the lead time as well.
  -Weekly updates of the progress with HPMM by slides.
  -Daily meeting with my site Manager and the Site Director the whole progress of the Plant
  -Setup Mainly heads up on the daily issues which are still open status.
  -Working with customer HPMM liaison for the preparation of machine landing, Power, CDA,
  Vacuum drops matrix & network status.
  -Working on the new machine buy off, MR checklist, CPM & Machine Equipmentʼs Calibration
  & PCL 1&2 Audit.
  -Develop the necessary technical competencies and equipment capabilities
  -Establish plans and strategies to meet and surpass manufacturing performance
  -Manage preventive maintenance and calibration.
  -Provide guidance and training to the Technicians
  -Ensure smooth start‑up of new equipment
  -Establish all equipment specifications, troubleshooting and PM procedures
  -Liaise with equipment vendors and spare parts suppliers
  -Manage equipment servicing contracts with suppliers
  -Drive the team to participate in all continuous improvement projects
  -Analyze process and machines performance including trouble shooting support, technical
  requirement with close partnership of other functional teams to drive through product.
  -Support production stabilization projects to achieve robust manufacturing
  -To work with internal and external partners & institutes for collaborative analysis
  -Systematic use of methods (e.g. 8D, DOE, FMEA, SPC, Fishbone Diagram, Trend Chart and
  etc) and tools to enhance results interpretation, including proper documentation
  -Ensure compliance to company policies and standards
  -Ensure compliance to RBA policies and standards
  -Responsible for the issuance of equipment/ devices/ spare part/ hardware/ accessories for
  plant and machines
  -Focal person to liaise with production/customer HPSG & HPMM on supplier quality issue
  related to incoming raw material (Plastic Body, Lid, Label, Bag, Acc Spring,1‑Up Carton, Disk
  valve, Septum Mazama, Acumen chip, Bottle, Ink, Pallet, etc ). Involved in liaising between
  supplier and R&D on NPI activity, quality improvement and engineering changes.
  -Any other reasonable task assigned by superior or management

-Will ensure and maintain the stability of processes, high quality standards and optimized throughputs for the machines at all time.
-Support the processes during production build as well as to develop/assist in developing new specific processes for new package introduction.
-Initiate cost reduction projects, productivity and yield improvement projects. Design and modify tooling, equipment or machinery for higher performance and efficiency.
-Generate and maintain process and equipment specifications as well as to provide training to operators and supervisor in specific processes.
-Plan and managed daily engineering runs and management of the yield, cycle time and report writing.
-Direct requirements.
-Front to end assembly process.
-Analyze process and machines performance including trouble shooting support, technical requirement with close partnership of other functional teams to drive through product.
-Improve process capability and production volume while maintaining and improving quality standards. Prepare samples for study.
-Provide suggestions during incident investigations and advise on corrective actions.

-Work on Improvement projects with respective Department to achieve the Customer Goal on Quality.
-To verify the Product Quality before approve to Pack.
-Certify EOL Operator New & Existing.
-Sent Report to HP daily as per requested.
-Communicate to PE regarding product Quality.
-To initiate all the log sheet, relate to EOL.
-Weekly Presentation regarding product Quality.
-Dashboard meeting regarding product Quality Failure Analyst.
-Operation Meeting ‑ Q90/OPEX.
-Sustain and provide continuous process improvement though planning, evaluating,
verifying and executing procedure to ensure that products meet customersʼ requirement in
terms of quality, yield and cycle time.
-To provide containment, analysis, interim and long term corrective action for any
discrepancies.
-Ensure flawless transition of product at the shortest possible time.
Initiate, support and carry out cost saving project.
-Liaise with customer and potential customers on deployments and improvements of
process, material and equipment capabilities.
-Identity and eliminate sources of failure and to improve the functionality of the product.
-Evaluate and establish process parameters.
-Troubleshoots process or product problem in order to minimize production downtime to
achieve product quality.
-Studies exiting process in order to meet optimize production requirement and quality.
-Coordinates with product development department regarding product failure and takes
necessary corrective action

-Supervise production section to ensure operation in controlling condition.
-Conduct on job trainee and test paper for new joined technician.
-Responsibility on spare part controlling and spare part order.
-Trouble shoot on major problem of machine and quality.
-Manage stable team to achieve production daily & monthly target output.
-Manage schedule plan for production running.
-Conduct on customer complaint and improvement project (six sigma, CIT, SMED and QRQC)
-Training awareness and conduct audit ISO TS16949 audit.
-Modification tool for machine and create new design tool and machine part.
-Conduct on monthly safety audit.
-Knowledge incoming material housing, terminal, emboss.
-Drive continuous improvement, cost reduction and design improvement for trouble free
-manufacturing process.
-Root cause investigation on abnormal process / customer complaints.
-Prepare and maintain the process documents such as W.I, as per ISO requirements.
-Setup and buy off for the new Assembly lines or Relay out / transfer of Assembly lines.
-Initiate Localization of items/parts/tools, to support Purchasing for New Vendor development.
-Support Product transfer from other sites for cost reduction programs.
-Design review on new machine tooling for new products.
-Involvement in the activities for new products or machines.
-Audit and qualified the new vendor or supplier.

-Controlling production and automatic insert machine
-Conduct on new machine and new product
-Controlling quality and quantity of production
-Controlling machine part and machine performance
-Responsibility on setup an FA sample making
-Provide feedback on daily issue to engineer
-Trouble shoot quality issue and machine problem.

-In charge and responsible on machining and Productivity improvement.
Control & plan day to day assignments to Subordinates.
-Provide effective leadership, guidance and training to subordinates.
-Ensure methods of handling utilization of equipment are properly correctly handled by subordinates.
-Supervise and ensure subordinates are carrying out daily activities effectively and efficiently.
-Prepare performance report for continues improvement in the following areas:
-Line down time report.
-Output performance report.
-Tools& equipmentʼs condition report
-Subordinates attendance & performance report