RESUME

NAGESWARA RAO MUNAGA

Mobile no: +861**********, +861**********

E-mail: adx2td@r.postjobfree.com

CAREER OBJECTIVE:

To make a challenging career by working in an esteemed organization where i can implement my experience and prove my technical skills to the fullest of my extent. If i am selected for the post, I can assure you that I will do my best and dedicated service to your organization.

PROFESSIONAL EXPERIENCE:

TOTAL EXPERIENCE: 14 years 7 months.

2020 December- Present.

Yangtze River Pharmaceutical Group, China.

Position: Technical scientist.

Reporting: Director.

Responsibilities:

Participate in Investigations for OOS, OOT and Deviations and execute CAPA.

Good safety, Health and Environment management in the laboratory.

Chromatographic data Processing review as per GCP.

Good exposure in chromatographic review, data review.

Organize team to carry out continuous optimization to improve compliance and work efficiency.

Strong communication and organization coordination ability, good planning management, presentation and reporting capability.

Involved in Internal, Customer and external regulatory audits.

Monitoring lab functions as per GMP.

2018 November- 2020October.

Asymchem Life Science (Tianjin) CO., Ltd, China.

Position: ARD Manager.

Reporting: Director.

Responsibilities:

Analytical method validation, verification, stress study of product and method transfer protocols preparation and change control preparation.

Analytical method validations, verification, stress study of product and method transfer protocols and reports review and change control review.

Communicating with clients or customer in the Tele Conference and discussing about projects status and none complies.

Training conduct for new joiners.

Participate in Investigations for OOS, OOT and Deviations and execute CAPA.

Good safety, Health and Environment management in the laboratory.

Chromatographic data Processing review as per GCP.

Good exposure in chromatographic review, data review.

Organize team to carry out continuous optimization to improve compliance and work efficiency.

Strong communication and organization coordination ability, good planning management, presentation and reporting capability.

Involved in Internal, Customer and external regulatory audits like USFDA and CFDA.

Monitoring lab functions as per GMP.

2016 April – 2018 0ctober.

Beijing Sciecure Pharmaceutical Co.Ltd, China.

Position: Analytical chemist.

Report: Manager and Director.

Responsibilities:

Analytical method validation, verification and method transfer for validated methods.

Participate in Investigations for OOS, OOT and Deviations and execute CAPA.

Sample analysis, data Processing and documentation as per GMP.

Good exposure in chromatographic analysis, data review, instruments calibrations, wet analysis and trouble shooting.

Cleaning validation, stress study of product as per protocol.

Involved in Internal, and external audits like Customer, USFDA, MHRA, TGA and WHO audits.

Lab instruments Calibration log books review.

Preparation of Analytical method validation, working standard protocols and reporting.

Online record updating, working based on CGMP.

To carry out the calibration of Instruments, maintaining log records.

Good exposure in chromatography, analysis, data review, instruments calibrations and trouble shooting.

Analysis data review of formulated products, and API materials with respect to specifications and customer requirements (instrumental & chemical).

2015 Sep – 2016 Feb.

Micro labs limited, Bangalore, India.

Position: Senior Executive.

Report: Manager and Director.

Responsibilities:

To carry out the calibration of instruments, maintaining log records.

Preparation of certificate of analysis. Follow up Calibration of Instruments as per the scheduling dates.

Good exposure in chromatography, analysis data review, instruments calibration trouble shooting.

Wet analysis data review of formulated products, APIs and its intermediates and Raw materials.

Dissolution testing of formulated products like capsules and tablets by HPLC or UV data review.

Online record maintenance and working based on CGLP. Work allocation and leading a team as per shift schedule.

Participate in Investigations for OOS, OOT and Deviations and execute CAPA.

Analysis electronic data review and documentation review.

Involved in Internal, and external audits like Customer, USFDA, MHRA TGA and WHO audits.

Lab instruments Calibration data review.

2013 Sep – 2015 Sep.

Cipla ltd, Bangalore, India.

Position: Management staff.

Report: Section head.

Responsibilities:

Participate in Investigations for OOS, OOT and Deviations and execute CAPA.

Analysis of electronic data Processing and submission (21CFR part 11).

Involved in Internal, and external audits like Customer, USFDA, MHRA TGA and WHO audits.

Work allocation and leading a team as per shift schedule.

Lab instruments Calibration data review.

Lab functions maintaining through Quality management system (QMS).

Stability samples analysis of data review.

Online record updating (Online documentation), working based on CGLP.

To carry out the calibration of instruments, maintaining log records

Good exposure in chromatography, analysis, data review, instruments calibrations and trouble shooting.

2010 Oct – 2013 July.

A.F.T. Pvt. Ltd, Hyderabad, India.

Position: Senior Chemist.

Report: Manager.

Responsibilities:

Analytical method validation, verification and method transfer for validated methods.

Participate in and lead Investigations for OOS, OOT and Deviations. Participate and execute CAPA.

Sample analysis, data Processing and documentation as per GLP.

Good exposure in chromatographic analysis (HPLC and GC), data review, instruments calibrations, wet analysis and trouble shooting.

Work allocation and leading a team as per shift schedule.

Cleaning validation, stress study of product as per protocol.

Determination of solution stability of product.

2005 August – 2007 September.

ALPHINE PHARMACEUTICALS Ltd, Hyderabad, India.

Position: Chemist.

Report: Manager.

Responsibilities:

Preparation of certificate of analysis. Follow up Calibration of Instruments as per the scheduling dates.

In process analysis both wet analysis and instrumentation analysis.

Good exposure in chromatography, analysis, instruments calibrations and trouble shooting.

Wet analysis data review of formulated products, APIs and its intermediates and Raw materials.

Preparation of volumetric solutions and standardization.

Good exposure in chromatographic analysis (HPLC and GC), instruments calibrations, wet analysis and trouble shooting.

Lab instruments Calibration data review.

Online record updating, working based on GLP

To carry out the calibration of equipments, instruments and maintaining log books.

In process samples, API and formulated products like capsules and tablets analysis.

TECHNICAL EXPERTISE:

HPLC,

GC,

Dissolution,

Polari meter,

UV- visible spectrophotometer,

Disintegration apparatus,

Dissolution apparatus.

INSTRUMENTS HANDLING:

HPLC-Waters (Empower Software), Shimadzu (LC Solutions Software) Agilent technologies(Open lab and Chromeline Software),

GC-Shimadzu (GC Solutions), Chemito GC-1000(IRIS-32),

UV-Visible spectrophotometer-Shimadzu,

Dissolution-Vision classic,

Disintegration test apparatus-Electro lab,

Friability –Erweka,

PH meter- Polmon,

MR meter –Polmon,

Analytical balance- Mettler Toledo,

KF Titrator- Polmon,

Polari meter-Advance,

TDS/Conductivity analyzer-Polmon,

UV Chamber-Vision.

EDUCATIONAL QUALIFICATIONS:

2010 M.Sc Analytical Chemistry from S.V.University, Thirupathi, A.P.

2005 B.Sc (BZC) from Acharya Nagarjuna University, Guntur, A.P.

PERSONAL DETAILS:

Father’s name: Ramulu,

Date of birth: 09/08/1985,

Sex: Male,

Marital Status: Married.

Nationality: Indian,

Languages known: Telugu, English, and Hindi,

Address for communication: H.No:5-32A, Chapala bazaar,

Dachepalli (villa & Mandal),

Guntur (Dist),

A.P, 522414.

DECLARATION:

I hereby declare that the above mentioned information is true to my knowledge and I bear responsibility for the correctness of the above mentioned particulars.

Place:

Date: (NAGESWARA RAO MUNAGA)

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