Ankamma Rao Resume 2109

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CURRICULUM VITAE

B. ANKAMMARAO
ASST. MANAGER-QC,
ITAAN PHARMA
STERILE PREPARATION.
Profile:
Mobile:
MSC Post Graduate with 10+ years of Professional Experience in Quality
+91 96034 68379
Control for formulation division of “Sterile Injectable, Oral Solids and API”
Email:
products.
[email protected]
Objective:
Professional Summary:
To associate myself with an organization that provides me an opportunity to
Total Experience: 10+ Years use my techno–proficient skills, improve my knowledge, and be a part of an

Permanent Address: organization, that works dynamically towards reaching the goals and growth
of the organization.
B.Anakammarao
S/o Venkata Krishna rao, Core Competencies:
Kakarlamudi (V),
 Work experience at a reputed firm with strong quality control
Chadalawada (PO),
Vemuru (M), Guntur (D), implementing cGMP and good documentation and laboratory
Pincode: 522301 practices in Quality Control department.
Personal Details:  Possess a clear understanding of the industry, technology trends and
process.
Father’s Venkata
Name Krishna rao,  Comprehensive experience in Quality Control with Regulatory
Date of requirements. Good Communication Skills and Document
04th Aug, 1995
Birth
Presentation.
Sex Male.
 Knowledge in Pharmaceuticals & Review skills, Training and
Nationality Indian.
Auditing Skills. Ability to communicate well and adapt to the
Languages English,
Known Telugu, Hindi. situation.
Marital
Single.  Good leadership qualities and Quick learner and goal oriented with
Status
timely manner.

Work Experience:
 Presently working in ITAAN Pharma Private Limited Hyderabad as
Asst. Manager in QC department.

 Worked in ASPIRO PHARMA., Sterile Preparation at


Karakapatla as Sr. Executive in QC department under From Nov
2021 to May 2023.
 Worked in Graviti Pharma Pvt Ltd Oral Solids at Pashamylaram,
Hyderabad as Quality Control Associative in QC department From
Oct 2018 to Nov 2021.

 Worked in Dr. Reddy’s Unit-I API Plant at Hyderabad as Team


member in QC department From Oct 2013 to Oct 2018.
Education:
 MSC (Organic Chemistry) - ANU University 2019 to 2021.
 BVOC (Pharmaceutical Chemistry) - A+ Grade 2015 to 2018
 Intermediate - K.V.S.R.T. Junior College, Chilumuru, A.P. 2010
to 2012
 S.S.C - C.V.R. High School, A.P. 2009 to 2010

Strengths

 Very flexible and adaptable to change.


 Responsible, operate with integrity and teamwork.
 Learning attitude and logical approach.
 Computer literacy skills in programs that apply to the role, solid
written and verbal communication skills.
 Ability to independently define problems, collect data, establish facts,
and draw conclusions.
Experience Details

 Current Working Profile Details:

Company
ITAAN Pharma Private Limited is an emerging Indian Pharmaceutical company with a
Profile
facility established in the year 2021. It is a green field project to supply US market.

Designation Asst. Manager - QC

Division RM, PM, IP, FP and GLP

 To ensure cGMP compliance with respect to Regulatory norms at QC.

 Vendor evaluation and qualification for starting materials and raw materials.

 Well versed in monitoring & Reviewing all QC activities related to Instrumentation, Wet
analysis, Stability and in process lab.
 Performed New Instrument Qualification Impact Assessments and conducted thorough supplier
assessments, followed by Installation Qualification (IQ), Operational Qualification (OQ), and
Performance Qualification (PQ) processes to ensure compliance and efficiency.

 Maintained comprehensive knowledge of all QC-related Standard Operating Procedures


(SOPs), including data integrity and password policy, while ensuring meticulous audit trails
and the creation of data files.

 Conducted and reviewed water validation in three phases, analyzing trends to ensure quality
standards were consistently met.
Work Profile  Prepared specifications for raw materials, packing materials, and finished products, including
Standard Test Procedures (STPs) and Analytical Work Sheets, adhering to pharmacopeia and
in-house methods.

 Planned and executed the sampling of raw and packing materials; conducted analyses and
subsequently reviewed documents for material release.

 Reviewed calibration records and monitored completed protocols and workbooks, ensuring
compliance with audit trails.

 Led vendor qualification evaluations and approval processes for key starting materials, packing
materials, and other necessary components.

 Applied extensive knowledge in Good Laboratory Practices (GLP) to enhance quality control
processes.

 Managed the raising and closing of Change Controls, including facility qualifications for the
QC lab and new instruments.
 Reviewed and released instrument calibrations as per the Master Calibration Schedule to ensure
operational readiness.

 Conducted training sessions on Good Documentation Practices (GDP), GLP, and current Good
Manufacturing Practices (cGMP) to promote a culture of quality within the team.

 Gained experience in facing audits, actively participating in the review of Quality Control and
Quality Assurance-related documents to ensure compliance.

 Demonstrated strong capabilities in raising and closing incidents and Out of Specification
(OOS) reports, contributing to continuous improvement initiatives.

 Previous Work Profile Details:

Company ASPIRO PHARMA , is a well-developed company manufacturing of sterile preparations and


Profile the plant is approved by USFDA,Ukraine, Russia, Europe & TGA ,Anvisa and other regulatory
bodies.

Designation Sr.Executive - QC

Division IP, FP and GLP

 To ensure cGMP compliance with respect to Regulatory norms at QC.

 Reviewed and released analyzed documents through the Laboratory Information Management
System (LIMS), ensuring compliance with quality standards and timelines.

 Demonstrated strong knowledge of change controls, Out of Specification (OOS) reports, and
incident management, including raising and closing processes to maintain regulatory
compliance.

 Conducted training sessions on instrument operations, including High-Performance Liquid


Chromatography (HPLC), to enhance team proficiency and adherence to best practices.

Work Profile  Managed materials analysis and coordinated review and release planning within established
timelines, collaborating effectively with cross-functional departments to optimize workflow.

 Utilized Empower 3 for creating instrument methods, processing data, performing sign-offs,
and maintaining audit trails to ensure data integrity and compliance.

 Ensured Good Laboratory Practice (GLP) activities were adhered to in the QC lab, fostering a
culture of quality and compliance.

 Planned and executed analysis for online samples and coordinated shift activities to ensure
timely releases and maintain operational efficiency. Review and approval of Specification and
Standard testing procedure.
Company Graviti Pharma Pvt Ltd is a well-developed company manufacturing of Oral Solids,the
Profile
plant is approved by USFDA and other regulatory bodies.

Designation Quality Control Associative


Division RM,PM
Work Profile  Performed Raw material and Packing material sampling to ensure quality compliance
throughout the production process.

 Attended training sessions on Good Documentation Practices (GDP), Good Laboratory


Practices (GLP), and current Good Manufacturing Practices (cGMP) to enhance operational
standards.

 Conducted water content analysis using Karl Fischer (KF) auto titrator with Tiamo software,
ensuring precise measurement and reporting.

 Executed daily calibrations on analytical balances, pH meters, and KF factors to maintain


instrument accuracy and reliability.

 Carried out comprehensive water sample analyses, verifying adherence to quality


specifications.

 Performed assays and organic impurities tests utilizing HPLC through Empower 3 software,
ensuring compliance with regulatory requirements.

 Analyzed samples for identification using FT-IR testing through Lab Solutions software,
confirming compound integrity.

 Prepared volumetric solutions and reagents in accordance with analysis requirements, ensuring
proper concentrations and accuracy.

 Evaluated working standards to maintain quality control throughout testing procedures.

 Conducted HPLC calibrations on Waters and Shimadzu instruments using Empower 3


software, ensuring optimal performance.

 Adhered strictly to cGMP, GLP, and GDP protocols to foster a culture of quality and
compliance within the lab environment.
Company Dr.Reddy’s Laboratories (Unit-I) is a well-developed company manufacturing of API
Profile ,the plant is approved by USFDA , EDQM , TGA and other regulatory bodies.
Designation Team Member-QC
Division RM,IP
Work Profile  Performed Raw material and Packing material sampling to ensure quality compliance
throughout the production process.

 Attended training sessions on Good Documentation Practices (GDP), Good Laboratory


Practices (GLP), and current Good Manufacturing Practices (cGMP) to enhance operational
standards.

 Conducted water content analysis using Karl Fischer (KF) auto titrator with Tiamo software,
ensuring precise measurement and reporting.

 Executed daily calibrations on analytical balances, pH meters, and KF factors to maintain


instrument accuracy and reliability.

 Carried out comprehensive water sample analyses, verifying adherence to quality


specifications.

 Performed assays and organic impurities tests utilizing HPLC through Empower 3 software,
ensuring compliance with regulatory requirements.

 Analyzed samples for identification using FT-IR testing through Lab Solutions software,
confirming compound integrity.

 Prepared volumetric solutions and reagents in accordance with analysis requirements, ensuring
proper concentrations and accuracy.

 Evaluated working standards to maintain quality control throughout testing procedures.

 Conducted HPLC calibrations on Waters and Shimadzu instruments using Empower 3


software, ensuring optimal performance.

 Adhered strictly to cGMP, GLP, and GDP protocols to foster a culture of quality and
compliance within the lab environment.
 Proficiently operated FTIR (Perkin Elmer & Spectrum Two) to conduct qualitative analysis and
confirm compound identity.

 Executed HPLC analyses using Waters and Agilent systems with Empower 3, Chromeleon, and
Lab Solutions, ensuring accurate quantification of active ingredients and impurities.

 Conducted UV spectrophotometry with Shimadzu and UV Probe software for concentration


determinations and purity assessments.

 Utilized various laboratory instruments, including pH meters, KF titrators, conductivity meters,


and analytical balances, to perform precise measurements in line with quality standards.

 Carried out moisture content analysis using halogen moisture analyzers and performed Residue
Knowledge On
Instruments of Ignition (ROI) tests to ensure compliance with specifications.

 Managed Thin Layer Chromatography (TLC) and Oven Loss on Drying (LOD) evaluations to
assess product quality and stability.

 Operated Gas Chromatography (GC) with Agilent instruments and Empower 3 for volatile
compound analysis, contributing to comprehensive quality assessments.

 Conducted Total Organic Carbon (TOC) analysis using Lab Solutions software to evaluate
water quality and ensure compliance with regulatory standards.

 Measured turbidity and performed osmotic pressure assessments with dedicated meters to
monitor water quality and ensure product integrity.

I hereby declare that the above-furnished information is true to the best of my awareness and please give me one opportunity
in your organization to prove myself.

Place: Hyderabad
Your’s faithfully,
Date: B. Ankammarao

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