Dinesh Kumar Singh

A career that is enriching in terms of inputs which provides ample scope for employing my abilities to achieve constant advancements. Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth. Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.

• Approved as “Manufacturing Chemist” in injectable section on Jan 2010 from Health & Family Welfare department, Himachal Pradesh.
• Approved as “Manufacturing Chemist” in injectable section in 2012 from Health & Family Welfare department, Andhra Pradesh.
• Approved as “Manufacturing Chemist” in injectable section in 2016 from Health & Family Welfare department, Maharashtra.
• Closer of deviation and CAPA pending from last one year after joining Wockhardt Ltd.
• Revised SOPs to include observation and made in line with cGMP at Wockhardt Ltd.
• Reduce the consumption of buffer solution and silicon tubing at Wockhardt Ltd.
• Workman orientation (Multiskilled) for running the machine in absence of any workman to execute the exhibit batches at Wockhardt Ltd.
• Removed the laminated hard copy of display SOPs from aseptic area by installing the touch screen computer system to display soft copy of SOPs.
• Minimization of vial rejection during washing at Hospira Healthcare Ltd.
• Revision of functional SOPs as per audit requirement at Aurobindo Pharma Ltd.

• SOP or work instruction development, preparation and execution.
• Coordination of preparation and implementation of SOPs.
• Development and preparation of BMR, Validation Protocol and Validation Report etc.
• Documents Preparation and changes in existing documents as per FDA and cGMP requirements.
• Co-ordination with stakeholder for scheduled / unscheduled activities.
• Spare parts maintenance related to production equipments.
• Ensure preventive maintenance schedule, validation schedule, calibration schedules and Documentation review.
• Validation Activities (Process Validation, Clean room Validation, Autoclave Validation, Depyrogenating tunnel validation, DHS validation, Washing machine validation, Filling machine validation, Lyophilizer Validation etc.).
• Daily and monthly Production Planning. Ensure plan vs actual output.
• Ensure Clean Room monitoring (Temp., Humidity, Diff. Pressure, Particle count).
• Actively engaged in dispensing, manufacturing and filling of large & small volume parenterals and lyophilized product.
• Routine Checking of BMR’s, daily Records and submitting to QA. Through review of executed BMR.
• Filling of Daily Production Report (DPR) and batch details.
• Batch yield monitoring / control and improvement.
• Preparation of monthly statistical data and monthly Presentation. Trend preparation as per SOP for NVPC, Temperature & RH, Interventions, Critical Alarms of Machine, Audio Visual Alarm, Batch Rejection Trend etc.
• Supervision of DM / DW Plant.
• Training of subordinate, operator and helper.
• Training through TRIMS, SABA, iso-Train and TMS.
• Raising indent as per requirements. Procurement of consumable through CAPEX or Purchase requisition.
• Raising SMR & SRN.
• Manpower management (No of manpower, work distribution etc).
• Initiation and handling of deviation, incidence and change control.
• Supervision of optical inspection and packing activities.
• Investigation of incidents and deviations.
• Preparation of BMR & BPR.
• Operation of Equipments.
• Conducting internal audit and compliance.
• Maintaining the good documentation in the production department
• URS preparation.
• Handling of Investigation and CAPA.
• Handling of Change control and deviation.
• Review all Investigation of OOS, OOT.
• Protocol Preparation.
• Continuous development project.
• Review of executed documents like validation report, trends, BMR.
• Gap analysis and its compliance.
• To establish discipline and team work.
• Dealing with business development team for finalization of sales order.
• Dealing with vendors associated with company.
• Dispatch of product as required by marketing / Business team.
• Troubleshooting associated with product execution.
• Procurement of consumables and resources required for Production.
• Finalization of vendors considering the quality and productivity.
• Any other responsibility assigned by Management or CFT member.

• MHRA
• USFDA
• ANVISA
• WHO-GMP
• FDA
• IDA Sudan
• ISO
• B/Braun
• Cipla
• Ranbaxy
• Promed Exports

• Two days GMP training by Mr.Atul Sirgoankar at Fresenius Kabi Oncology Ltd.
• Seminar on "Biological Indicators And Sterilization Process" held on 22 March 2010 at Taj Hotel, Chandigarh on behalf of FKOL.
• One day GMP training by DUPONT on “Advanced Fiber System” in Chandigarh on behalf of FKOL.
• Training attended on Bio-Decontamination at Aurobindo Pharma Ltd. Unit- 12 by Bioquell UK Ltd on 12 Dec.2011.
• Training attended on Presentation skill.

• Got award for quiz contest at Fresenius Kabi Oncology Ltd.
• Got Excellence Performance award by Ahlcon Parenterals (I) Ltd.
• Actively participated in health camp organized by S.G.R.R.I.T.S. Dehradoon during National Pharmacy week.
• Got appreciation letter for investigating batch failure at Intas Pharma Ltd.

• Date of Birth: 06/03/82
• Nationality: Indian
• Marital Status: Married

• Mr. Vishal Sharma, Alembic, Vadodara, GJ, 09959220610, vishalsharma1857@gmail.com
• Mr. Rohit Modi, Acme Life Science, Baddi, H.P., 09817781025, rrmodiin@gmail.com