B N V V D PRAVEEN

adzrcj@r.postjobfree.com

+91-897*******

About 18 years of impeccable experience in Quality Control, Quality Assurance and Analytical Method Validations with exemplary laboratory exposure. 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.

Perusing Ph.D – Chemistry dept. in GITAM university (part-time)

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

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

• Currently working with Graviti Pharmaceuticals Pvt Limited – An US-FDA approved Formulations Company in Hyderabad as AGM – Quality since 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 Jun- 2007 to Sept-2012).

• Worked with Natco Parenteral Limited in QC as a Chemist (From Jul-2005 to May-2007

• My expertise in Quality Control dept. which involves mentoring, supervising, developing staff and planning testing on Drug Substances and Drug Products for In-process and Finished products, Calibrations, Stability analysis, Analytical method validations and overall GLP activities.

• Significant contribution in handling of 6 US-FDA inspections during the periods of Jan- 2023, Apr-2018, Aug-2017, Apr-2016, Jun-2015 and Mar-2013 & successfully completed without any major observations with cross functional team support.

• Accompanying auditors during regulatory and customer audits & provide assurance on quality compliance systems.

Current Job responsibilities:

• Responsible for AQA, QMS, Vendor Qualification, Audit and Compliance activities in QA dept.

WORK EXPERIENCE:

CAREER OBJECTIVE:

EDUCATIONAL QUALFICATION:

PROFILE AT A GLANCE:

WORK EXPERIENCE

• Responsible for overall Quality Control activities for the following on day-to day activities (from Jun-2017 to Jul-2020)

GLP / lab support team (Instrument management, Standard management, Columns management, Analyst Qualifications and Trainings etc).

In-process & Finished Product team for commercial manufacturing products

Stability management team for exhibit and commercial products, In-use study, Split studies etc.

Documentation team (SOP’s, STP’s, Specifications, Master worksheets etc.).

Leading Investigation team to handle all laboratory Incidents (PNC’s) and Out of specification results.

All laboratory related QMS activities such as Change Controls, Deviations, CAPA etc. and closely monitoring of its target timelines and completions.

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

Review of Analytical Method validations protocols and Reports.

• Laboratory Information Management System (caliberLIMS) implementation, timely coordination with Caliber team and ensure successful and smooth implementation of software’s at within the targeted timeline.

• Monitoring and Review of New Equipment Qualifications (IQ, OQ & PQ), SOP preparations and provide trainings to user teams.

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

• Responsible for ensuring the laboratory on any time readiness to the audits.

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

• Continuous review the guidelines and harmonize the instrument calibrations to in-line with regulated procedures.

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

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

• 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.

• 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.

• Closely worked with External Quality Consultants (Meridan Consulting, USA, Sree Consulting, and PharmQA Compliance etc.) for third party review of investigations. Re- open the investigations where necessary with CAPA’s to strengthen the investigation as per regulatory expectations.

• Currently leading Quality Management Systems (QMS) and Analytical Quality Assurance related activities (from July-2020 to till date). QMS activities / Responsibilities include:

Handling and Closure of Change Controls

Handling and Closure of Deviations/Incident/CAPA

Handling of Customer Complaints

Regulatory/Customer audits

Handling of Investigations such as Process Non-Conformances (PNC), Laboratory Incidents, Out of Trends (OOT), Out of Expectations (OOE), Out of Specifications (OOS) etc.

Scheduling and Management of Self-Inspections (Internal Audits).

Management Quality Review Meetings (QMRM) – presenting the QMS elements to management on quarterly basis.

Preparation of Quality Agreements for Contract manufacturing services and Contract testing laboratories.

AQA activities / Responsibilities include:

Review and Approval of analytical documents received from all sections in QC

Review of batch related audit trials on daily basis.

Participate in all the investigations occurred in QC and perform the investigations in thorough, timely, unbiassed and result oriented to identify exact root causes, assess the impact and to propose and implementation of appropriate CAPA’s.

Ensure all computerized systems used in laboratory are in qualified state.

Periodical laboratory rounds to ensure that personnel involved in lab activities are following GLP practices during their routine work.

Prioritize the work by discussion with CFT’s and manufacturing / dispatch plans.

Review and Approval of Analytical Method validation / verification protocols and reports

Regulatory support.

Review and Approval of Instrument Qualification protocols meant for laboratory instruments

Review of periodical calibrations data for laboratory instruments

Management of Stability chambers and samples charged for stability, loading and withdrawls etc.

Management of Reserve samples, Visual inspection etc.

Verification of Data back-up and Retrieval studies are performed as per written policy

Other Responsibilities include:

• Vendor Qualification: Conducting vendor audits for contract manufacturing services and contract testing labs and preparation/review of vendor audit reports.

• Review of analytical data in APQR’s and Continuous Process Verification and responsible to perform necessary investigations wherever applicable.

• Documentation cell management: Control and issuance of all master documents such as SOP’s, Work sheets and BMR’s etc.

Previous job experience:

• Complete Analysis of Injectables & lyophilized products of CCD (oncology) products, Tablets, Capsules for In-process, finished product and Stability testing.

• Planning & Work allotment, Review and Approval of all QC related transactions.

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

• Assign & review daily group activities.

• Preparation / review of incident / Laboratory Investigation report (IR & LIR) summary

(trend) & train all chemists to avoid its re-occurrence.

• LIMS implementation in QC laboratory.

• Perform method transfer analysis according to the protocols.

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

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

• Provided support to AR&D dept. for the review, evaluation, improvement of test methods (if any).

• Successful coordination for the various regulatory & customer audits such as North-star Healthcare, AbbVie, Avion, Ingenus, GSK, Romania, GCC, Ukraine, WHO and Brazil- ANVISA.

HPLC (Waters, Agilent and Shimadzu) with Empower 3 & 2 software.

Gas Chromatography (Agilent with Empower & Chemstation software).

UV-Visible Spectrophotometer (Shimadzu-2450 & 1800).

Dissolution Apparatus (Electrolab, Varian & Lab India).

Atomic Absorption Spectrometer (Shimadzu)

FTIR (Shimadzu & Bruker).

Other lab instruments such as Karl-Fischer Titrator, Differential scanning calorimeter

(DSC), Nano-RAM spectrometer (B&W Tec) 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.

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. INSTRUMENTS HANDLED:

TECHNICAL STRENGTHS:

Good communication skills.

Flexible, Hard & smart 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.

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

Father’s name : Vijaya Kumar

Date of Birth : 6

th

Aug 1984

Sex : Male

Marital Status : Married

Nationality : Indian

Languages Known : English, Telugu, and Hindi

Mailing Address : Flat No: 1502, Block-G, Aparna Serene Park, Masjid Banda main road, Backside of SBI quarters,

Kondapur, Serilingampalli mandal,

Hyderabad, Telangana – 500084

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

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)

STRENGTHS:

PERSONAL PROFILE:

DECLARATION:

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