Carrier Objective :
Looking for a challenging and responsible position to work in an organization in which I can exhibit my technical skills in achieving the desired objectives of the organization and willingness to learn and grow with the organization.
Professional Summary :
Pharma Formulations (Sterile & non sterile) Processional having 8 years of experience in Analytical Quality control functions.
Currently working with M/S Shilpa Medicare Ltd (Sterile Oncology Formulations), Jadcherla as a Section In chargeFP, GLP & Lab Compliance in QC Department.
Having an experience of regulatory inspections from USFDA, UKMHRA, TGA, MCC, ANVISA, WHO (Geneva), North Star, Uganda and other regulatory inspections for both Sterilie & Non Sterile product division and Onco Division. Handle the Internal Audits. etc.
Drug control Approved Chemist.
Excellent written and oral communication skills to communicate effectively with cross functional teams.
Core Competencies :
Good exposure of Oral solid Dosage Forms (Tablets, Capsules, Syrups) and Injectables (General and Oncology products).
Analytical Method Technology Transfer and Method Validation activities.
Handling and investigation of Laboratory Incidents, OOS, OOT and Change controls.
Analytical Review of Quality control related documents and ensure the Lab compliance.
Good experience on Calibration of analytical instruments and Instrument Qualifications (IQ/OQ/PQ).
Preparation of System & General SOPs, STPs, Specifications, protocols and Worksheet Templates as per Regulatory requirements.
Good experience on Evaluation of Working Standards, Stability studies Microbiology activities.
Good experience on Chromeleon, Empower LC Solutions and Chemstation Software’s.
Experience in all the functions of QC viz., Finished Product, Process Validation, Raw material, Stability, Packaging materials, GLP (Calibrations) and Analytical compliance.
Interfacing with Caliber LIMS Software (2.0 & 3.0 ver.) and ERP for registrations, work allotment, worksheet taking, online entries and review.
Implementation of good laboratory practices in the QC laboratory and ensures cGMP, GLP compliance and GDP and trained the newly joined analysts.
Good experience on Project stage. (To setup the QC dept during project time).
Ensure the availability of sufficient chemicals, manpower, necessary equipments etc.
Organizational Experience :
1) Organization Name : SHILPA MEDICARE LIMITED (Sterile Oncology injectables).
Designation : Section In chargeFP, GLP & Lab Compliance.
Duration Period : May 30th 2012 to till date.,
Job Responsibilities :
Work allocation to team, planning and maintaining a 10 number of team of analysts.
To monitor the every analyst during the Analysis and to check as per GLP compliance.
Expertise on review of Analytical reports of finished, in process, validation reports, analytical method validations and Analytical Method Transfer for HPLC and others.
Familiar with Calibration of analytical instruments and Review of Calibration reports for all analytical equipments.
Involved in Instrument/Equipments Qualifications activities.
Conducting & Handling of Analytical Method transfer activities.
Preparation of the investigation report for OOS and OOT and Laboratory Incidents.
Preparation and management of Working standards and reference standards.
Strong experience in handling and trouble shouting of analytical instruments.
Water Validations. Analysis of in process, Stability, Validation and Finished product samples.
Establish specifications for new drug substances / dosage forms and review of specifications, test procedures and Preparation of SOPs.
Preparation of monthly work flow which includes working criteria of my Team and same information is being shared to my hiericals.
2) Organization Name : AUROBINDO PHARMA LIMITED (Formulation-OSD)
Designation : Executive – QC (Analytical Compliance).
Duration Period : May 9th 2008 to May 2012.
Job Responsibilities :
Responsible for timely release of Quality control samples with complies and to reach the monthly targets.
Responsible for calibration of Analytical Instruments.
Responsible for Qualification of working standards.
Initiate & closing of Lab incidents, Change controls, CRF, Deviation, OOS and OOT.
Responsible for Analysis of Exhibit, Commercial batches Innovator Samples.
Experience in Review of Raw Data and performance activities, using LIMS.
Analysis of, FP, In-Process samples and Packing material as per Customer and Regulatory requirements.
Good experience on Analysis like RS, Dissolution, Assay, CU, Calibrations and other Physical parameters.
Review of Microbiology EMR Validation Protocols, MLT Protocols, Chemical & Water and EMR annual Trends.
Monitor & involved in Microbiology area activities.
Representative as a core team member during the audits of various regulatory bodies i.e.USFDA, MHRA, ANVISA, WHO, MCC, TGA and other’s.
3) Organization Name : GLAND PHARMA LIMITED (Sterile injectables).
Designation : Jr.Executive – QC
Duration Period : May 2005 to May 2008
Job Responsibilities :
Sampling and testing of Water analysis, raw materials, in-process, finished samples.
Testing of stability samples as per the stability protocol.
Preparation of SOPs, STP,s and GTPs and Specifications.
Calibration, Handling and maintenance of laboratory instruments like HPLC, U.V., F.T.I.R., and TOC.
Reviews of analytical reports of finished product, Raw material and Stability.
Laboratory compliance with respect to audit commence by external regulatory bodies
Having an experience of regulatory inspections from USFDA, UKMHRA, TGA, MCC, ANVISA, WHO (Geneva) and Customer based inspections.
Instrumental Exposure :
HPLC Waters, Agilent, Shimadzu with Chromeleon, Empower, LCS
UV & GC PerkinElmer & Shimadzu
DISSOLUTION Electrolab, Lab India and Distek.
FTIR PerkinElmer
TOC GE Analytical
Other Instruments : LBPC, Osmometer, Polarimeter, Viscometer, KF & Autotitrator, MLPA, BSA, DTA, Turbidity & DO meter, TDA,THT,Fraibility, EMSS, PFT,SVM,.
Equipments : Glove box, Isolator, Incubators and Stability chambers.
Academic Profile :
Degree University Aggregate Year of Passing
Master of Science Periyar University 60% 2005(2003-2005)
Bachelor of Science S.V.University 66% 2003(2000-2003)
10+2(Intermediate) APRJC, Board of AP 68% 1999(1997-1999)
S.S.C APRSC, Board of AP 78% 1997
Exposure of Audits & Inspections :
USFDA, MHRA & WHO at APL Unit-III, Gland Pharma Hyderabad location.
TGA & MCC at APL Unit-III Hyderabad location.
ANVISA at APL Unit-III & Gland Pharma Hyderabad location.
UGANDA, NORTH STAR, PFIZER Inspection at APL Unit III
USFDA, MHRA, ANVISA, WHO, TGA inspection at formulation Unit III at Hyderabad : Where there were no major points related to quality control department.
Customer and Internal Audits and inspections at APL Unit-III, GPL, Shilpa Medicare Ltd.
Personnel Info :
Marital Status : Married.
Languages known : Telugu, English, Hindi and Tamil.
Declaration :
I hereby declare all the above given information is correct and true to best of my knowledge and belief.
Place : Hyderabad
Date :