From:

B.R.Suresh Reddy
Flat No.: 113
Vindhya Apartments
Near South India Shopping Mall
Ameerpet
Hyderabad
Telangana. Mobile No: 90599 83204

To:

The HR Department,

Dear Sir,

Myself Ramasuresh Reddy Bade, M.sc, in Microbiology with about 18 Years

of experience in Quality Control / Quality Assurance Department.

At present I am working as a Quality Control Manager in Shilpa Therapeutics Pvt. Ltd,

(Shilpa Medicare Limited) Cherlapally, Hyderabad.

Specialties: Expertise in management of Quality systems like Change control, OOS, OOT,
Maintenance of master copies, Analyst qualifications, Audit trials, 21CFR compliance, Internal
quality audits and review of analytical documents like (protocols, Record of analysis,
Chromatograms and report), Specifications, stability data, SOP's Instrument.

I am aware of GLP and Quality Systems and having a knowledge and vision on analytical
developmental activities, I hope the acquired knowledge will be best suitable for your
organization.

Sincerely,

Ramasuresh Reddy Bade

Page 1 of 6
 CURRICULUM VITAE

Ramasuresh Reddy Bade

Mail ID: ramasureshreddy@gmail.com

Mobile: 90599 83204

Career Objective

To associate myself with a reputed pharma company where I can explore my knowledge and
ability, to improve my knowledge and to be a part of the team that works dynamically towards
the growth of the organization
Asset
Ø Aptitude to learn new ideas and quicker adaptation to the environment, multidimensional
view of a problem, good communication skills, willingness to learn, amicable team
member.
Ø Good exposure towards quality systems, method validations, stability studies and GLP
compliance.
1. Quick decision making
2. Good Leadership skills

Academic Qualification

Degree University Year of Completion

Master of Science in Nagarjuna University, Guntur,

April 2003
Microbiology (M.Sc.) Andhra Pradesh
Andhra University,
Bachelor of Science (B.S.C) April 2000
Bhimavaram, Andhra Pradesh

Area of interest

· Quality Control
· Analytical Quality Assurance
· Analytical Research & Development
· Regulatory Affairs (if requires)

Page 2 of 6
Summary of the work experience

Total Experience: 18 years

 Experience on review of Analytical documents, stability studies, method validations,

Spec & STP, GLP and GMP.
 Experience on quality systems like, change control, incidents, OOS, OOT.
 Experience on internal and external audits (NPRA Malaysia, TFDA, Kenya, Uganda
and WHO GMP).
 Experience on Audit trials (For Chromeleon software) and ensuring 21CFR
compliance.
 Experience on Solid oral dosage forms and External applications (Tablets, Capsules,
Pellets, Oral Liquids, Sachets, Oral fast dissolving films, Ointments, Lotions and
Creams).

Present: M/s. Shilpa Therapeutics Private Limited, (Shilpa Medicare Limited).

Well reputed Organization situated in Cherlapally, Hyderabad, it is completely engaged in
manufacturing of Oral fast dissolving films. This organization is having NPRA, TFDA and
WHO GMP.
Tenure: September 2016 to Till date. Position: Manager - Quality Control.

Key responsible areas:

 Responsible for the overall Quality control functions to establish, document and
maintain a quality system ensuring that product conforms to specified requirements.

 Control over day-to-day activities of QC Dept. (Wet lab, Instrumentation and Microbiology)
for smooth lab operation as well as timely release of product.
 Preparation of master planner for Calibration, Preventive maintenance and AMC for all
instruments.
 To provide QC support to regulatory department for new product submissions.
 Review of protocols, record of analysis, chromatogram reports, change requests, incidents, if
any.
 Perform timely review and approval of executed record of analysis (ROA’s) as per the
approved current version of specification and method of analysis.
 Review and approval of analytical method validation protocol, document and report.
 Review and approval of specification and method of analysis.
 Perform and review of audit trails for all non-chromatographic quality control
laboratory instruments.
 Perform and reviews of audit trial verification of Chromeleon Chromatographic data
system.
 Perform and review of audit trial verification of standalone instruments.
Page 3 of 6
  Handling of OOS & OOT.
 Analyst Qualification: Review of Record of analysis, Chromatograms and reports.
 Instrument/Equipment Qualification: Review of URS, Protocols and reports.
 Stability Studies: Review of Protocols, Record of analysis, chromatograms and reports.
 Review of Instrument calibration schedule and reports.
 To conduct training to the concerned departments as per the pre-determined schedule.
 Performing work independently and maintain the team members.
 Review of record of analysis for Microbiological testing of water (TAMC, TYMC) and
test for specified Microorganisms (E.coli, Salmonella, Staphylococcus aureus and
Pseudomonas aeruginosa) in raw materials and finished products.
 Review of Environmental monitoring data of microorganisms. (Settle plate and Air
sampling).
 Approved Chemist in Chemical, Instrumentation & Microbiology in Form 25 and
Form 28.

Previous: M/s. Jivanta Laboratories Private Limited (SH Pharmaceuticals Limited)

Well reputed Organization situated in Uttarakhand, Haridwar, it is completely engaged in
manufacturing of formulations. (Tablets, Capsules, Oral Liquids and Ointments). This
organization is having WHO GMP approval.
Tenure: October 2006 to October 2015. Position: Sr. Manager in Quality Control and
Quality Assurance Department.

Key responsible areas:

 Overall responsibility of planning and execution of both QC and QA department.

 Handlings of Internal and External Audits and customer complaints.
 Review and approval of core QA functions including Change controls, Deviations, Incidents
and Annual product reviews.
 Training conducting to the concerned departments as per the pre-determined schedule
 Reviewing Batch Production Record
 Good knowledge on reviewing of Qualifications (DQ, IQ, OQ & PQ)
 Instrument/Equipment Qualification: Review of URS, Protocols and reports.
 Internal Audits: Planning & performing internal audits.
 Validations: Review of Protocols and Reports for Process validation and Analytical method
validation, Record of analysis, chromatograms, reports. Change requests, incidents, deviations
if any.
 Review of Related substance, Assay and Dissolution documents.
 Preparing SOP's, STP's and all QA and QC related Documents.
Page 4 of 6
  Audit trials for 21CFR Compliance: Performing audit trial for Empower 3 data.
 Analyst Qualification: Review of Record of analysis, Chromatograms and reports.
 Monitoring and closing of event of/ Incidents reports and review of the investigation reports.
 Review and Approval of Specification and method of analysis.

Previous: M/s. Metrochem API Private Limited, UNIT- II.

Well reputed Organization situated in Jeedimetla, Hyderabad. It is completely engaged in
manufacturing of pellets.
Tenure: June 2005 to September 2006. Position: QC In charge

Key responsible areas:

 To follow up analysis of Raw materials, Packing materials, In process and Finished product
samples.
 To follow up analysis of Stability samples.
 To prepare specifications and standard testing procedures for Raw materials, Packing
materials, In process, Finished product and Stability samples.
 To prepare analytical raw data sheet for Raw materials, Packing materials, In process,
Finished product and Stability samples.
 To calibrate quality control instruments as per schedule.
 To follow up preventive maintenance and AMC of quality control instruments.
 Training of quality control chemists.
 To qualify working standards as per schedule.
 To prepare stability protocol, Stability data compilation report (Accelerated, Long term,
Intermediate and Long term IV –B.
 To prepare monthly and annual calendar for stability samples.
 To indent Reference standards, Impurities, Calibration Standards, Chemicals, Columns and
Glassware etc.

Previous: M/s. Venkat pharma Limited.

Well reputed Organization situated in Nacharam, Hyderabad. It is completely engaged in
manufacturing of OSD formulations.
Tenure: May 2003 to June 2005. Position: QC Executive

Key responsible areas:

 Sampling and analysis of Raw materials and Packing materials.

 Daily Verification of balance, pH meter and Conductivity meter.
 To determine factor daily for KF Apparatus.

Page 5 of 6
  To calibrate UV – Visible spectrophotometer and FTIR as per Schedule.
 To prepare specifications for Raw materials and Packing materials.

Instruments Exposure:

Ø HPLC – Waters, Shimadzu and Thermo Dionex system with UV,

RI and PDA
Detector (Chromeleon, Lab solution and Empower 3 Software)
Ø GC – Thermo (Chromeleon Software)
Ø UV – Visible Spectrophotometer (Perkin Elmer, Shimadzu and
Lab India)
Ø FTIR – Shimadzu
Ø Dissolution Apparatus USP I & II (Electrolab)
Ø DT Apparatus (Electrolab)
Ø Friability Apparatus (DBK)
Ø KF auto titrator (Metrohm and Lab India)
Ø Digital Viscometer (Brook Field)
Ø Polarimeter (Anton paar)
Ø Refractometer (Rudolph)
Ø UV Cabinet (Biotechnics)
Ø Stability Chambers (Thermo)
Ø Milli Q system and PAL
Ø Toc Analyzer (Sievers)
Ø pH meter (Henna and Mettler toledo)
Ø Conductivity meter (Henna and Mettler toledo)
Ø Turbidity meter and other QC related Instruments

PERSONAL PROFILE

Father's Name Anji Reddy Bade

E-mail ID: ramasureshreddy@gmail.com
Date of Birth: 15th June' 1980
Marital Status: Married
Languages Known English, Telugu and Hindi
Permanent Address B.Nidamanur (Village &Post),
Naguluppalapadu (Mandal}, Prakasam Dt, AP.
DECLARATION:
As such I am requesting you sir/madam that give me an opportunity work under your
organization, I assure you that I can discharge my duties to the utmost satisfaction of my
superiors.

Yours Faithfully
Place: Hyderabad. (Ramasuresh Reddy Bade)
Page 6 of 6