Naresh Kumar S
Production Manager
Sudair,Saudi Arabia
Summary
A dedicated and highly motivated team player with a strong understanding of cGMP and USFDA guidelines. Demonstrates quick learning abilities and adaptability to new methods and systems. Committed to achieving excellence in professional endeavours while continuously enhancing skills and knowledge.
Overview
26
26
years of professional experience
1
1
Certification
Work history
Technology Transfer & AMV Manager
Sudair pharmaceutical Company
Sudair, Saudi Arabia
05.2025 - Current
- Taking care of Greenfield project for manufacturing of Sterile Insulin project
Plant Manager
Menagen pharmaceutical Company
Muscat, Oman
07.2024 - 03.2025
- Accountable for Daily site activities of production and engineering department.
- Responsible for Manufacturing of Sterile Injectables, Oral Solid Dosage forms and Packaging Activities.
- Managing day to day engineering related activities
Production Manager
Sudair pharmaceutical Company
Riyadh
10.2015 - 07.2024
- Accountable for daily manufacturing operations, production scheduling, and raw materials.
- Managing 3 lines i.e., OSD oncology manufacturing line with Isolators including dispensing, granulation, blending, compression, capsule filling, coating, Sterile oncology manufacturing line including dispensing, pre-Formulations/Formulations, Vial filling/Lyophilization process, Syringe Filling line including formulation, Filling, syringe/Vial inspection labeling and secondary packaging etc.
- Handling new project from construction stage, Preparation of URS for correct required equipment’s, attending FAT/SAT, Involved in Equipment installation and qualifications, Successful Media fill runs and continued production processes.
- Successful handling of Technology Transfer for 10 products (OSD and Sterile) stability batches, then continued for commercial production
- Having good experience in OSD/Sterile Equipment’s Validation protocols preparation and successful execution.
- Dirty equipment/Clean equipment holding time studies managed successfully.
- Involved in Primary & Secondary packaging machines selection, installations and Qualifications and successfully managed for production processes as per Technology Transfer requirements.
- Actively participated in equipment’s validations IQ, OQ and PQ
- Preparation and execution all OSD line/Sterile line/Packaging line documentation like SOP’S, protocols, personnel flow, material flow and waste material flows etc.
- Well-handled without Major observations audits like SFDA GMP Certifications for all lines, GCC audits, Lebanon GMP Audits, Novartis Audits, Dr.Reddy’s Audit, CIPLA Audit etc.
- Develop and execute production schedules based on business demands
- Actively participated in all type of validations for cleanrooms.
- Successfully completed for around 20 products OSD and Sterile process validations.
- Coordinating with supply chain to deliver products on time.
- Coordinating with R&D department to develop new products with existing machines
- Coordinating with other departments like material availability, in process and final checks and on line documentation
- Having good exposure in SAP entries.
Formulation and Filling Supervisor
ARABIO (Arab Company for Pharmaceutical Products)
12.2009 - 07.2015
- Develop and execute production schedules based on business demands
- Maximize effectiveness of production team, equipment and materials to produce multi-line products within planned schedules while reducing costs
- Lead, develop and evaluate production staff of X members
- Manage activities related to strategic purchasing to minimize operating expenses
- Control inventory and raw material handling
- Ensure safe work environment through implementation of safety awareness programs and compliance with OHSA
- Design, implement and audit quality control processes
- Develop technical documents including instruction manuals and procedure manuals
- Manage scheduling of shipping dates for all incoming orders
- Supervised the daily set-ups and start-ups of production equipment
- Supervised the assembly and packing of high volume runs
- Monitored cost and quality of production
- Integrated and developed new team members
- Implemented preventive maintenance program for production facilities
- Instituted and monitored safe work practice procedures to maintain an injury-free and efficient production facility
- Conducted quality control inspections
- Achieved a consistent record of improving production runs and reducing costs
- Expert in prepare the documents like., SOP’s, BMR (Batch Manufacturing Records), BPR (Batch Packaging Records), URS etc.
- Ensuring packing of oral dosage forms as per procedure
- Manage the aseptic filling activities in Classified areas
- Expert to manage the filling activities different size of dose volumes (Syringes/Vials) by preparing the different type of recipes on PLC machines.
- Good knowledge about operating PLC machines
- Expert to handle Martin Christ Lyophilizer like create the different type of recipes and operate according to the recipes.
- Trained in Novartis for formulation, blending and filling operations of Meningitis vaccine
- Trained in Crucell for formulation, blending and filling operations of Penta vaccines
- Trained in Novartis for formulation, blending and filling operations of Flu vaccines.
- Good knowledge in prepare the Mediafill BMR and perform the mediafill activities for all filling lines.
- To keep the balances / equipments/ instruments in calibrated state.
- To operate, clean and maintain the manufacturing equipments as per the written procedures
- Control of Aseptic operations.
- Review of Documents related to aseptic operations.
- Maintain Class 100, 10000 and Class 100000.
Production Sr.Executive
Orchid Chemicals and Pharmaceuticals Ltd
Chennai
12.2002 - 12.2009
- Hands on experience in Crystallization, Blending, and material-to-material mixing, sterilization and sanitization process, adjusting PH in bulk material and Follow the process as given SOP’s.
- Hands on Experience in Operation, Maintenance and Cleaning of Crystallizer, Agitated Nutch filters, machine, Blenders, Sifters, Water for Injection (WFI-Multi still Column), Centrifuge, Vacuum tray driers, Glass lined Reactor (GLR), Stain less Reactors (SSR), Filter Integrity testing machines, Automated sterilization process systems, Steam heat sterilizer (SHS), Dry heat sterilizer (DHS) and Fluidized bed drier etc.
- Involved in different processes of Solid sterile bulk Drug production development cycle like batch charging, material formation, material drying and packing , timely giving in process samples, Raw materials, Sifting, Blending, Milling, looking after troubleshooting, stage wise yield calculation, label and weigh finished products as per Sop’s.
- Working in manufacturing of Sterile Bulk forms including active and non-active ingredients, sifting, blending, and milling.
- Worked with In-process checking, line clearance data maintenance, follow cGMP regulation in various stages in production
- Prepare and Maintain various BPR (production batch record), reconciliation records and in-process check records
- Participate and getting certificate in WHMIS (Working Hazard Material Information Systems) and MSDS (Material Safety Data Sheets)
- Performed all duties as per the instructions of Batch manufacturing record (BMR), standard Operating procedures (SOP’s), standard cleaning procedures (Sop’s).
- Involved in Cleaning, Setting and Operating of various machines according to SOP’s
- Periodic inspection and maintenance of Schedules and its documentation
- Follow the Batch Process Procedures, In-process quality control (IPQC) monitoring and documenting as per SOP’s and GMP guidelines.
- Experienced in Trouble shooting in case of machine default.
- Involved in investigations for Deviations and Out Of Specification results.
- Follow and maintain cGMP, Standard Operating Procedures (SOP), Health and Safety policies.
- Involved in Cleaning, Setting and Operating of various machines and rooms according to Standard Operating Procedures (SOP’s).
- Filled batch-manufacturing records of on-going products and entered data on line in the SAP.
- Sent in-process samples to QC for analysis.
- Ensure cleaning of area and cleaning of all the machines after product is over.
- Prepare and execution of IQ, OQ and PQ documents for HVAC, Equipments, Machineries etc.
Production Chemist
Dr.Reddy's Laboratories
Vizag
04.2000 - 12.2002
- Manufacturing the bulk actives and active Pharmaceutical ingredients and generic formulations
- Monitoring equipment parameters and operational norms with conformance to Standard Operating Procedures (SOP) and compliance cGMP. A detailed process diagram (P&ID) making available for the processes to identify the unit operations, equipment used, staged at various substances are added (Flow Charts) key steps in the process, critical parameters (time, temperature, pressure etc.) and monitoring points.
- Significant process steps phase changes involving either the desired molecule or the solvent inert carrier e.g. dissolution, crystallization, evaporation, distillation and pH adjustment in intermediate process. Phase separations such as filtration, any chemical changes involving the desired molecules, e.g. removal (azo collection) or addition of water (hydration)
- Impurities, contaminants, carriers, vehicles, inert, dilutes and/or unwanted crystalline or molecular forms which may be present in the raw materials, drugs are largely removed by various treatments like extractions, washings etc. in the experiments or production process.
- Mother liquors containing recoverable amounts of Bulk pharmaceutical chemicals are freely re-using. Such re-using may consists of employing the mother liquor to dissolve the reactants in the next run of that step in the synthesis re-use may also consists.
Education
Master’s Degree In Science (M.Sc.) - Chemistry
Madurai Kamaraj University
Bachelors Degree In Science (B.Sc) - Chemistry
Diploma - computer applications MS-Office &SAP (Word, Excel & Outlook)
Skills
- Dedicated and highly motivated team player
- Quick learner and easy adaptability to new methods and systems
- Good Understanding of cGMP, and USFDA Guidelines
Certification
- Steam Heat Sterilizer Validation:
- Heat Distribution study and cold point detection.
- Heat Penetration Study with Maximum and Minimum Load.
- Review of validation documents.
- Dry Heat Sterilizer Validation:
- Sterilization Process Validation:
- Heat Distribution study and cold point detection in Reactor, Aseptic Filtration System, Agitated Nutsche Filter Drier and Blenders.
- Process Simulation Validation using Lactose:
- Aseptic Process simulation using Lactose.
- Training of personnel for process simulation studies.
- Process Validation of Sterile Drugs:
- Holding Time Study of the Sterile Drugs.
- Concurrent Process Validation of the Sterile Drugs.
- Sterilized tools and Garments Storage:
- Storage Time Study for the Sterilized tools and Garments with the help of Microbiology.
- Disinfectant Solution Validation:
- Effective dilution and usage frequency validation with QC Microbiology.
- HVAC System Validation:
- Integrity of the System, Cleanliness level monitoring and Uniformity checking in the area.
- Velocity and Air-changes calculation for the Clean Rooms.
Languages
English
Telugu
Tamil
Hindi
REFERENCES
Available upon request.
Covering Letter
- Attn: Human Resources Recruiter Application for the post of:
- Dear Sir / Mam
- I am very enthusiastic to work in your Manufacturing Department (OSD & Fill finish). I have a master’s degree in chemistry, which has been accredited by the Madurai Kamaraj University
- I have 25 years of experience in pharmaceutical Manufacturing, Vaccine Manufacturing including formulation and filling, sterile formulation, Fill Finish, API manufacturing & Filling, Formulation including OSD Oncology manufacturing, OSD General formulation manufacturing and exposure in Projects and have good knowledge about SFDA, USFDA, UK MCA, and WHO GMP approved Organizations.
- My success in the past has stemmed from a strong commitment to hard work, a sense of professionalism, and dedication to any responsibility. I am sure that my strong background and related work experience will enable me to meet the demands of the position and allow me to apply my knowledge.
- Thank you for taking time to review my application and I appreciate your consideration and look forward to hearing from you shortly.
- Yours truly
- (Naresh Kumar.S)
Personal Profile
- Father’s Name : Venkanna.S
- Date of Birth : 1978-07-06
- Sex : Male
- Nationality & Religion: Indian & Hindu
- Marital Status : Married
- Languages Known : English, Telugu, Tamil and Hindi
- Passport No : S0816148
- Competency : Planning, Organizing, Analysis.
- Present Address : Sudair, Saudi Arabia
- Permanent Address : Sai Nagar Colony, Hayat Nagar, Rangareddy, Telangana, India
Timeline
Technology Transfer & AMV Manager
Sudair pharmaceutical Company
05.2025 - Current
Plant Manager
Menagen pharmaceutical Company
07.2024 - 03.2025
Production Manager
Sudair pharmaceutical Company
10.2015 - 07.2024
Formulation and Filling Supervisor
ARABIO (Arab Company for Pharmaceutical Products)
12.2009 - 07.2015
Production Sr.Executive
Orchid Chemicals and Pharmaceuticals Ltd
12.2002 - 12.2009
Production Chemist
Dr.Reddy's Laboratories
04.2000 - 12.2002
Bachelors Degree In Science (B.Sc) - Chemistry
Diploma - computer applications MS-Office &SAP (Word, Excel & Outlook)
Master’s Degree In Science (M.Sc.) - Chemistry
Madurai Kamaraj University