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Manager Quality Control

Location:
Malaysia
Posted:
May 17, 2019

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Resume:

B N V V D PRAVEEN

ac9eer@r.postjobfree.com

+91-897*******

WORK EXPERIENCE:

About 14 years of impeccable experience in Quality Control (Formulation) and Analytical Validations with exemplary laboratory exposure.

CAREER OBJECTIVE:

I am interested in a position where I can increase my leadership abilities through highly articulate, demonstrating excellent relationship building, communication, analytical and interpersonal skills, regularly encountering and solving problems besides having cutting edge in my discipline and work as a team player to achieve goals of the organization.

EDUCATIONAL QUALFICATION:

Master’s in Sciences (M.S-Pharmaceutics) from BITS-Pilani.

Bachelor of Pharmacy (B.Pharm) from JNT University.

PROFILE AT A GLANCE:

Currently working with Graviti Pharmaceuticals Pvt Limited – An US-FDA approved Formulations Company in Hyderabad as Manager in Quality Control from Jun-2017.

Worked with Novast Laboratories Limited – An US-FDA approved Formulations Company in Nantong, CHINA as Manager in Quality Control (From Oct-2012 to Apr-2017).

Worked with Dr. Reddy’s Laboratories Limited in QC as a Junior Manager (From Jul-2007 to Sep-2012) and Natco Parenterals Limited as QC/A Chemist (From Jul-2005 to May-2007).

As a Manager in Quality control laboratory, Currently I am managing the Quality Control dept. which involves mentoring, supervising, developing staff and planning experiments on Drug Substances and Drug Products for In-process and Finished products, Calibrations, Stability analysis and overall GLP activities.

My expertise in Method Developments and Method Validations for various Drug Products (Oral Contraceptives, Immediate Release, and Controlled Release Solid Dosage Forms) and drug substances.

WORK EXPERIENCE

Job responsibilities:

Leading the following teams in Quality Control lab with a team size of 15.

API and In-process & Finished Product team for commercial manufacturing products

GLP team for lab support.

Analytical Data Review team to ensure the compliance of all tasks performed in QC lab as per written procedures.

Analytical Method validations and Method Transfers.

As a project coordinator for LIMS, QAMS and Training software’s, timely coordination with vendors and ensure successful and smooth implementation of software’s at within the targeted timeline.

Participated in 5 US-FDA inspections during the periods of Apr-2018, Aug-2017, Apr-2016, Jun-2015 and Mar-2013 & successfully completed without any major observations with cross functional team support.

Coordinate with auditors during regulatory and customer audits & provide assurance on lab compliance system. Successful coordination for the various regulatory & customer audits such as cFDA, North-star Healthcare, AbbVie, Avion, Ingenus, Biocon, Upsher smith and Mylan etc.

Ensure timely completion of instrument calibrations and maintenance as per schedule for all QC related instruments.

Preparation & Revision of Standard Test Procedures, Specifications and Standard Operating Procedures routing through change controls.

Report Incidents/Process Non-conformances, OOT & OOS and perform laboratory investigations accordingly to identify the root-cause and propose/implement appropriate CAPA’s.

Provided support to Analytical Research dept for the review, evaluation, improvement of test methods (if any).

Review system audit trails for empower data and ensure Periodical back-up of laboratory electronic data.

Review of New Equipment Qualifications documents (IQ, OQ & PQ).

Ensure laboratory data integrity by timely review of the project audit trails.

Review training matrix schedule and provide necessary trainings to new employees as prequalification & training program.

Preparation / review of Analytical method validation protocols and reports.

Assign & review daily group activities.

Periodical preparation / review of incident / Laboratory Investigation report (IR & LIR) summary & train all chemists to avoid its re-occurrence.

Prepare / Review Stability protocols and management of for stability sample analysis, data review, reports and summary.

Ensure the practice of lab safety & GLP compliance.

Coordinate with cross functional departments such as AR, QA, PD, Production and Engineering as required.

Previous job experience:

Complete Analysis of Tablets, Capsules, Injectables & lyophilized products for in-process and finished product testing.

Planning & Work allotment, Review and Approval of all QC related transactions in “Laboratory Information Management System (LIMS)”

Calibrations and performance verifications of all quality control related instruments based on the schedule and update the same in Master calibration/ Performance verification.

Perform method transfer analysis according to the protocols.

Perform analytical method validations for Assay, BUCU, Dissolution & Impurities and preparation of validation reports.

Qualification of In-house reference standards /working standards against Pharmacopoeial standards.

Successful coordination for the various regulatory & customer audits such as GSK, Romania, GCC, Ukraine, WHO and Brazil-ANVISA.

INSTRUMENTS HANDLED:

HPLC (Waters & Agilent with Empower 2 & 3 software & Chemstation software.

Gas Chromatography (Agilent 6890N with Chemstation & Empower software).

UV-Visible Spectrophotometer (Shimadzu-2450).

Dissolution Apparatus (Electrolab, Varian & Lab India).

FTIR (Shimadzu).

Other lab instruments such as Karl-Fischer Titrator, Atomic absorption spectrometer, Differential scanning calorimeter, Nano RAM spectrometer, Melting point Apparatus, Disintegration Test Apparatus, Friability test apparatus, Density tester Apparatus, Sieve Shaker, Halogen moisture content analyzer, pH meter, Rotary evaporator, and vacuum hot air oven, Karl-Fischer titrator and titration methods etc.

TECHNICAL STRENGTHS:

Proficient in deployment & implementation of Laboratory Information Management System (LIMS) in Quality Control laboratory.

Perform QC related transactions in SAP.

Handling Change Controls, Deviations, Incidents using QAMS.

Proficient in using Microsoft Word, Excel and PowerPoint.

Operating Systems – Windows XP, Windows 7 & Windows 8 & Windows 10.

STRENGTHS:

Good communication skills.

Flexible, Hard working, Honest and Determination.

Perseverance and ability to learn the new concepts quickly.

Ability to lead others in demanding circumstances and remain calm in the stressful situations.

PERSONAL PROFILE:

Name : B.N.V.V.D.Praveen

Father’s name : Vijaya Kumar

Date of Birth : 6th Aug 1984

Sex : Male

Marital Status : Married

Nationality : Indian

Languages Known : English, Telugu, and Hindi

Mailing Address : Flat No: 203, Block-A, Vijaya Raghava Township,

Nallagandla road, Serilingampalli mandal,

Hyderabad, Telangana – 500019

Phone: +91-897*******

DECLARATION:

I consider myself with the above mentioned aspects. I hereby declare that the

above details furnished are true to the best of my knowledge and belief.

(B N V V D Praveen)



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