CURRICULAM VITAE

PRATHAP GONELA Mobile: +91-810*******,

+91-994*******.

e-mail: adkhu8@r.postjobfree.com

CAREER OBJECTIVE:

A Quality oriented professional with over 11 years 4 months of experience in pharmaceutical industry seeking to leverage my technical and professional expertise to grow in a new role.

PROFILE SUMMARY:

Currently working as Assistant manager QA at JUBILANT GENERICS LIMITED Mysore, since July 2018 to till date.

Associated with BIOCON LTD Bangalore as Senior Executive Quality since April 2015 to July 2018.

Worked as Officer Quality Hikal LTD Bangalore, since August 2013 to March 2015.

Worked as Assistant QC at Aurobindo Pharma LTD, Hyderabad since July 2009 to August 2013.

ACADEMIC BACKGROUND:

M.Sc. (ORGANIC CHEMISTRY) from Periyar University, Salem, Tamilnadu with an aggregate of 62% in the year of 2006-08.

B.Sc. (Maths, Physics, Chemistry) from S.V University, Tirupati, Andhra Pradesh with an aggregate of 60% in the year of 2003-06.

TECHNICAL EXPERIENCE AND RESPONSIBILITIES:

Quality Assurance –Assistant Manager(Jubilant generics LTD: July-2018 to till date):

Review and Approval of analytical document received from QC department prior to batch release.

Thorough working knowledge on QMS, laboratory investigations:

OOS/OOT, Deviations, and Laboratory Incidents with root cause analysis for establishment of CAPA Processes &Effectiveness checks through Track wise application.

Coordinating with the cross functional teams to fulfil quality requirements and documentation related activities in the QMS investigations.

Evaluation of change management and CAPA effectiveness checks proposals and monitoring.

Collaborate and approval of analytical work sheets, Master STPs, Stability Protocols & Reports through EDMS software.

Conducting Quality audits (Internal audits/Gemba Walks) as per the schedule including preparation of audit agenda, execution of audit and preparation of audit report. Post audit follow up for timely closure of audit observations and implementation of the necessary CAPA within the stipulated time.

Escalation of critical audit observations to the higher management through management notifications and to support the site to implement the same.

Preparation and review of Annual product review of various products.

Review of Method transfer /verification protocols, User requirement specifications (URS), IQ/OQ/PQ &CSV documentation, SOPs, Risk assessment.

Hands on experience in reviewing computer system validations according to 21 CFR part 11 and FDA regulations for the pharmaceutical industries.

Working knowledge of GLP/GMP/GAMP-V guidelines especially in the areas of computerized systems.

Experience in GAP analysis and documenting remediation plan.

Conducting periodic trainings on Quality culture and SOPs.

Excellent knowledge and experience in Good documentation practices.

Familiar with all QC analytical instrumentation and Wet chemistry.

Senior Executive –Quality (Biocon LTD, Tenure:April-2015 to July-2018):

Worked as Team lead of the Finished Products and Stability team size of 8 members.

Planning and allocation of the work schedules to the analyses & review.

Responsible for the inceptions and with drawls of the stability samples & monitoring through Novalims software.

Responsible for Batch releases from QC and QMS investigations & closures.

Deeply involved in the laboratory investigations like OOS /OOT, Deviations, Laboratory incidents, initiations of change controls and so on.

Ensure and maintaining a safe and clean work environment by following current good manufacturing practices (CGMP), housekeeping and standard operating procedures.

Monitoring online documentation (GDP), compliance in our team and adhere to GLP.

Officer –Quality (Hikal LTD, Period: August 2013 to March2015):

Worked as Quality Control analyst in the finished product team.

Hands on experience on the analytical instruments: HPLC, GC, IC, SOR, Malvern PSD, FTIR, UV and Wet Chemistry and so on.

Adhere to GLP and GDP practices in the laboratory.

Assistant –Quality Control (Aurobindo Pharma LTD, Period: July 2009-August 2013):

I started my career as In-process QC chemist and responsible for the analysis of water content by KF auto-titrator with TIAMO software and verification of PH of the Reaction mass samples.

I worked in the QC teams like In-process, Raw material and Intermediate& Finished product teams in wet analyses as an analyst.

Performed wet chemistry analysis procedures like LOD, ROI, SOR Heavy metals, Bulk density and control sample record maintenance.

Performed the HPLC reaction mass analyses for supporting the In-process operations in the plant.

Personal Profile: Date of Birth: 31-05-1986; Nationality: Indian;

Passport # : Z4187370, Marital Status: Married.

Languages Known: Telugu, English Kannada and Tamil & Hindi.

Present Address: #65, M-block, Behind Allahabad bank, Kuvempu Nagara, Mysore,

Karnataka-570023.

Permanent Address: S/o Gonela Krishnaiah, Kappaladoruvu (vill), Valluru (post),

Muthukur (Mandal), Nellore (District), Andhra Pradesh- 524344.

Declaration:

I hereby declared that the furnished above information is true to the best of my knowledge and belief.

PLACE: Mysore

Date: PRATHAP.G

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