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COVERING LETTER
Respected Sir/Madam,
At the outset, Let me introduce about myself, I am G.Srinivasa Reddy, Completed
my Master of pharmacy from Andhra University having 2+ years work experience in
Technology Transfer Department. I am very much interested to work for your organization.
I would be delighted to work in your organization, if I am offered such opportunity.
Kindly find my resume here, in which I mentioned my exposure in PDL&TT activities. I would
like to draw your kind attention for the perusal of my CV and to consider my application for the
position. I will be privileged if I get an opportunity to work with you.
Looking forward to hearing from your end.
Thanking you for your valuable time and consideration.
G.Srinivas Reddy
RESUME
SRINIVASA REDDY GOLI
Contact Mobile +91-9494551043 E-Mail: [email protected]
+91-8523052943 [email protected]
Career objective:
• Aspiring to work with an organization where I would be given an opportunity to explore
myself to deliver outstanding service to my employer and grow along with the employer,
enrich professionally as well as personally.
Work experience:
Having 2+ years experience in Technology Transfer Department and Process
improvement in the Pharmaceutical Industry, Presently working with Hetero Labs LTD, based
at Jeedimetla, Hyderabad, as a Research Associate in Technology Transfer Department, since
October 2012 to till date.
Areas of Interest:
Technology Transfer department and Production
Formulation Research & Development
Job profile:
• To implement and follow the policies and procedure for efficient functioning of the
facility and equipment.
• Planning of trials in coordination with other cross functional teams.
• Strict adherence to the standard operating procedure and cGMP requirements.
• Maintaining online documentation pertaining to the executed batches at Process
development laboratory.
• Handling of Scale up, ANDA exhibit Batches, Site transfer and Validation batches along
with the R&D, QA and Production personnel as required.
• To ensure that the discipline is maintained at the shop floor.
• Brief Description of Job responsibilities during the scale up / process development /
execution of different batches.
Scale up:
• Review of the Pre scale up data and development records received from FR&D.
• Check for the feasibility of equipments for the process & proposing the batch size in
coordination with FR&D.
• Process understanding, anticipate the process criticalities & scale up hurdles and
monitoring the same during execution.
• Identification of Critical process parameters discussed and same shall be noted for the
training of Production batches.
• Review of Scale up BMR, Sampling plan received from FR&D.
• Execution of scale up batches in coordination with FR&D.
• Process Trouble shooting (if any) in coordination with FR&D.
• Preparation of Scale up report and finalizing the critical process control parameters.
Exhibit Batch manufacturing and Handling of In house developed Products:
• Co ordinate with FR&D and QA/Manufacturing in getting the desired license from
STATE REGULATORY authorities.
• Finalization of batch size and process to be used for manufacturing of the Exhibit
batches.
• Identify the equipments, tooling for tablets and capsules, change parts for packaging.
• Review of BMR and BPR for manufacturing and packaging of the batches.
• Monitoring the Exhibit batch manufacturing along with FR&D, Production and QA
Personnel.
• Check for any discrepancies if any shall be addressed.
• Facilitate the execution of Exhibit batch process monitoring / Validation Protocol. • Coordinate with Validation team for sampling plan preparation of
Validation/Commercial batches.
• Preparation of Process monitoring report.
• Preparation / Review of Intended BMR and BPR.
• Maintaining Change controls, deviations and out-of-specifications.
• Ensuring the timely availability of all the product specific related documents to
regulatory department for filing purpose
• Expertise in Wurster technology, Mups technology, Extrusion and spheronization and
successfully handled 10 molecules from scale up to till commercialization in all type
of formulations like wet granulation,wurster process(Top and Bottom spray), Roller
compactor etc.
Site transfer projects (Third party):
• Initiate New Product introduction for applicable export site transfer products.
• To provide technical details of the new product for the assessment of manufacturing
feasibility.
• To initiate change control for new product introduction for applicable export site transfer
products.
• Shall review the batch size proposals in coordination with the production people.
• Identify the vendor s for new raw material.
• Development of alternate vendor.
• Preparation of Vendor suitability reports in coordination with CQA.
• Coordinate and planning of the validation batches manufactured at third party site.
• Preparation of Technology transfer completion report after successful completion of
Validation Batches
• Act as an interface between the PDT and pilot plant.
• Develop robust and scalable formulations while ensuring timely product launch.
• Interact regularly with AR&D, FR&D, Packaging and Pilot Plant.
• Study the scalability of the formulation in detail.
• Prepare scale up Batch production report, sampling protocols & stability protocols.
• Provide inputs on equipments & process with reference to facilities and equipments at
various manufacturing locations.
• Monitoring the performance qualification of equipments.
• Ensure that the formulation being developed is robust and scalable.
• Look at the reproducibility of the formulation throughout its development.
• Predict the difficulties and problems that can occur during scale up of the formulation.
• Find solutions in consultation with FR&D team for obstacles that can come during scale
up.
• Consult pilot plant to solve any issues related to the scalability of the formulation.
• Facilitate technology transfer from lab to plant.
• Initiation of Checklist for submission Batch and issue them to different departments and
check their status to fix the time lines to take exhibit batch.
• Execution of process qualification, exhibit and validation batches in production.
• Preparation / Review for master formula cards, Batch Processing Record, Process
qualification Protocols, Process validation protocols and stability protocols.
• Preparation / Review of development reports, Process qualification reports, Process
validation reports.
• Preparation of Technology transfer dossier after successfully completion of validation
batches.
• Ensuring the timely availability of all the product specific related documents to
regulatory department for filing purpose.
• Ensuring the timely availability of all the product specific related documents to
regulatory department for filing purpose.
Technical Skills:
Instruments & Equipments Familiarity:
• Granulation equipments (Rapid Mixing Granulator).
• Drying Equipments (Fluid Bed drier).
• Rotary Compression machine.
• Coating pan (Conventional, Neocota )
• Fluid bed Pellets Coating (Umang Pharmatech and Palm Glatt).
• Capsulation machine (AF25T &AF90T-ACG).
• Hot Melt Extruder(Thermofischer)
• Roller compactor(Alexander Wercia)
Non Technical Skills:
• Good communication skills.
• Ability to lead a team.
• Good Presentation skills.
Academic profile:
M.Pharmacy from 2009-2011(Aditya college of pharmacy affiliated to the Andra
University, Visakhapatnam).
Bachelor in pharmacy from 2004-2008 (V.L College of Pharmacy affiliated to Rajiv
Gandhi University, Raichur, Karnataka).
Intermediate from 2002-2004 (Sri Sishya junior college affiliated to the Board of
Intermediate Education, Andhrapradesh).
10th from 2002 (MG High school, Pragadavaram)
Strengths:
Team oriented, self learning, Leadership ability.
Computer skills:
DCA, MS-office, C-language, SAP
Soft Skills:
• Problem solving ability, quick learner, takes complete ownership of activities assigned.
• Ability to lead a team / strong Individual Contributor.
• Manage project details while balancing multiple priorities.
• Able to operate in an environment with changing priorities and the need to respond
quickly to situations.
• Strong communication and people management skills.
Achievements:
Attended to the 60th IPC held at New Delhi.
Attended to the National conference on pharmaceutical microbiology.
Known languages:
English, Hindi, Telugu.
Personal details:
Fathers name : Mr. G.Prabhakara Reddy
Gender : Male
Date of birth : 06-06-1987
Nationality : Indian
Marital status : Single
Permanent address : Srinivas reddy s/o Prabhakara Reddy
Pragadavaram (post),
Chintalapudi (mandal),
West Godavari (District) – 534461,
Andhra Pradesh, India.
Declaration:
I hereby declare that the information furnished above is true to the best of my knowledge
and belief.
Date: 20-12-2014 Yours Sincerely
Place: Hyderabad Srinivas Reddy.
Reference:
1. Suresh Kolli
Dy.Manager.
Formulation research & development
Hetero Labs Ltd, Unit-III,
Hyderabad.
Ph. No: 09390077293
2. V.R. Sirisha K
Sr. Research Associate
Formulation research & development
Hetero Labs Ltd, Unit-III,
Hyderabad.
Ph. No: 09989871787
