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Quality Assurance/ Regulatory Affairs Executive Resume Sample, Experience : 8 years

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Name of the Candidate:[Private]
Name of the Post Applied:Quality Assurance/ Regulatory Affairs Executive
Job related skills / software:Annual Product Quality Review, GTPs
Category:Medical
Sub Category:Quality Assurance Executive
Years of Experience:8 years
State:Andhra Pradesh
Gender:Male
Salary Expected per Month(Rs):Negotiable
Highest Qualification attained:M.Sc. / MSC : Master of Science
Major / Specialization:Analytical Chemistry
Email Id:[Private]
 
Are you looking for job now?:No
Can the recruiter contact you?:No
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CAREER OBJECTIVE :
To make inroads in an organization that gives me scope and wide spread opportunities to apply my knowledge and innovative skill, spearheading the task that has been assigned with undivided devotion & dedication leaving no stone unturned the pinnacle glory of the esteemed organization.

PROFESSIONAL EXPERIENCE :
DR.REDDY’S LABORATORIES LIMITED APRIL 2009 TO TILL DATE
Presently working with M/s. Dr.reddy’s laboratory Limited, Hyderabad as a Senior Executive Quality Assurance from April 2009 to till date.
HETERO DRUGS LIMITED JUNE 2007 TO MARCH 2009
Previously worked with M/s. Hetero Drugs Limited, Jeedimetla Hyderabad, and Andhrapradesh in Quality Control Department formulation Unit III since June 2007 to March 2009.
DIVI’S CHEMICAL LABORATORIES LIMITED APRIL 2004 TO MARCH 2005
Career started with M/s. Divi’s Chemical Laboratories Limited, Lingojigudem Village Chotappal Md, Nalgonda Dt as a Chemist Quality Control Department from April 2004 to March 2005.

JOB RESPONSIBILITIES :
CURRENT ORGANIZATION  : DR.REDDY’S LABORATORIES LIMITED
Designation  : Senior Executive
Dr.reddy’s laboratory Limited is one of the leading pharmaceutical company in India. This organization is engaged in manufacturing & exporting of various Oral and Sterile formulations, Active Pharmaceutical Ingredients & Intermediates and the manufacturing facilities are approved by various prime regulatory authorities i.e.USFDA, MHRA, TGA, Health Canada, EDQM & Health care and WHO.

KEY RESPONSIBILITIES  :
Major contribution with analytical compliance activities (OOS, OOT Incidents, deviations, team member of quality risk management (QRM) and conduct process capability study.
Analytical Assurance
Review of Analytical documents within the prescribed timelines.
Review of Method Validation protocols and report before and after approval.
Verification of specifications /Standard test Procedures/GTPs/Work sheets/Analytical
Reports /SOPs and approval.
Review of Change controls and providing necessary support for closure of CC.
Review and Investigation of OOT, OOS and Incidents, their adequate disposal.
Handling of Deviations and CAPA and ensuring their implementation.
Training of QA personal and new recruits.
Providing adequate support to manufacturing assurance.
Providing adequate support to RA for dossier submission and addressing deficiencies.
Review, Evaluation and approval of Reduced Testing Proposals for Raw materials and blend stage.
To ensure cGMP and GLP compliance.
To follow good Safety, Health and Environmental procedures and practices.
Review of Vendor qualification reports
Annual product quality Review (APQR)

Documentation Assurance :
Handling of Change Request Note’s – Logging, circulating for approval, correcting necessary documents ensuring changes are effected and disposal of Change Request Note’s.
Issue and control of written procedures (Specification’s / Standard Test Procedure’s / Standard Operating Procedure’s / Standard Cleaning Procedure’s / Guidelines / Artworks etc.).
Issue of Batch Production Record’s and worksheets for Record of Analysis.
Preparation of Analysis Reports and Certificate of Analysis.
Reconciliation of Batch Production Record’s and Record of Analysis.
Storage and retrieval of all completed documents.
Issue of documents to Audit & Compliance Department for presubmission audits.
Issue of Documents to Regulatory Department for Submissions.
Scanning and Uploading of Master documents in Lotus.
Ensuring of Inspection plans and Record of Analysis uploading in SAP (Systems, Applications and Products in Data Processing).

Validation :
Planning and execution of activities related to Process Validations (Including Manufacturing & Packing)
Review and Release of batches for further processing.
Verification of Validation / Sampling / Stability Protocols before and after approval.
Approval of master documents such as, specifications, Standard testing procedures, Stability, sampling protocols.
Ensuring stability loading for validation batches as per requirements.
Review and approval of change controls.
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And deviations.
Compilation of Dissolution profile of the Exhibit and Pre validation batch.
Review of Dossiers/Common Technical documents

PREVIOUS ORGANIZATION 2  : HETERO DRUGS LIMITED
Position  : Quality Control Executive.
Hetero Drugs Limited is one of the largest and most paramount pharmaceutical companies of India. This organization is engaged in manufacturing & exporting of various formulations, Active Pharmaceutical Ingredients & Intermediates and the manufacturing facilities are approved by various leading regulatory authorities i.e.USFDA, MHRA, TGA, Health Canada, EDQM & Health care and WHO.
Major contribution with Stability study, review of analytical reports and stability data submitted to Regulatory Affairs.
Analysis of Stability samples (Accelerated, Intermediate and Long term), InProcess, finished, validation.
Calibration of all Analytical Equipments.
Review of Daily Temp Records. And Stability Chambers Management of Analysis Samples.
Review and Approval Analytical Reports , Daily Balance Calibration, KF factor Report
Preparation and Review of Stability Protocols, STP, Work Sheets And Validation XL Sheets.
Preparation And Submission of stability Data, Trend charts And Formats in MS Word And XL As per Requirement of QA, RA, R&D.
Active participation of Regulatory audits.
Investigation of OOT, OOS and Incidence.
Verification of columns, standards, chemicals and reagents And Handling of ERP and LIMS.

PREVIOUS ORGANIZATION – 1  : DIVI’S CHEMICAL LABORATORIES LIMITED
Position  : Quality Control Chemist.
Divi’s Chemical Laboratories Limited is one of the reputed bulk drug companies in Hyderabad, A.P. This organization is engaged in manufacturing & exporting of various Active Pharmaceutical Ingredients & Intermediates and the manufacturing facilities are approved by various leading regulatory bodies i.e.USFDA, MHRA.
Responsible for quality control related activities
Preparation of SOP’s, Specifications, COA’s,
analysis of raw materials and finished API
Calibration of quality control related equipments
Sampling done through equipments tray drier, finger bag drier. SS reactors, glass line reactors

ACADEMIC PROFILE :
Obtained M.Sc. Analytical Chemistry (20052007) from Nagarjuna University, Andhra Pradesh. India.
Obtained B.Sc. M.P.C (20012004) from Nagarjuna University, Andhra Pradesh. India.

COMPUTER SKILLS  :
Familiar with M.S.WORD, M.S.Excell, Windows XP, Lotus Notes, MS OfficeOut look and Internet net browsing.SAP, ERP, NOVATECH, LIMS.
Obtained PGDCA in Computers (20062007) from universal institute of Computer technology, India.

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