T.G.P.CHANDRA SEKHAR

Mail: actcec@r.postjobfree.com

Ph.No: +919*********

Objective:

To work in an organization that gives me a chance to update my knowledge, enhance my skills and to be a member of a team that excels in working towards the growth of the organization

Professional Summary:

5.0 years of Industrial experience in Quality Assurance, Qualifications and Validations, of Pharmaceutical Formulations (Solid Orals & Steriles).

Commissioning and Qualification of Green-field Projects (Facilities, Equipment, Utilities, Systems).

Capable of Preparation and review of Qualification Protocols.

Capable of Execution and Documentation of Equipment Qualifications IQ, OQ & PQ.

Capable of monitoring QMS activities.

Review of Computer System Validation (CSV) protocols and knowledge on Delta V Operation.

Knowledge on 21 CFR.

Projects, Qualifications & Validations Handled:

Working as Executive (E3) QA Projects for Qualification & Validations of Sterile Injectable Green-filed Projects.

Currently working on Dolphin Project (Hospira at Vishakapatnam), with CAI (Commissioning Agent Inc. a leading global consultant in US).

Executed Qualification activities of FEDEGARI Autoclave, IMA Life filling machine & BOC EDWARDS Lyophilizers.

Executed Qualification activities of Pharma Lab Pure Steam Generation (PSG), WFI generation and distribution.

Involved in the facility (HVAC) and Equipment qualifications of vial line and Ophthalmic line.

Educational Profile:

Master of Pharmacy with Pharmaceutics specialization in Annamacharya College of Pharmacy. Affiliated to JNTU Anantapur with an aggregate of 74.08%.

Bachelor of Pharmacy from Dr.Samuel George Institute of Pharmaceutical Sciences, Affiliated to Acharya Nagarjuna University with an aggregate of 66.44%.

Pursuing Executive Diploma in Pharmaceutical Regularity Affairs from IGMP University Delhi.

CURRENT ORGANIZATION

Hyde Engineering + Consulting Ltd, August 2014 - Till Date

Executive (E3) Projects QA

Hyde Engineering consulting Ltd., is a US based leading consultant for Pharma and Biopharma industries in global level.

Responsibilities:

Preparation and execution of Commissioning protocols.

Preparation and review of Qualification Documents URS, DQ, FAT, SAT, IQ, OQ & PQ protocols of various pharmaceutical equipments.

Review of Turn over Package (TOP).

Review and execution of P&ID’s and welding documents.

Review Material test Reports (MTRs).

Preparation and review of risk assessments and impact analysis.

Handling of Change Controls and Deviations related to qualification activities.

Preparation and review of commissioning closing reports.

Preparation of validation master plan (VMP).

Preparation, review and approval of SOPs & SOIs in compliance with GMP guidelines and regulations.

Active team member for the QA documentation support team for Nipro Pharma Vietnam.

Review of Computer System Validation (CSV) protocols.

Involved in the execution computer system validation (CSV)

Gland Pharma Limited, Hyderabad, India April 2013 –July 2014

Approved by USFDA, MHRA, ANVISA & TGA

Dy.Chemist QA Projects

Responsibilities:

Preparation and review of validation protocols, summary reports and SOPs.

Executed qualifications like IQ, OQ, PQ of equipments, systems and utilities Green fields Projects.

Executed qualification of Autoclave (Pharma lab & Fedegari), Vial washing machine & Filling Machine (Snowbell) and Lyophilizer (BOC EDWARDS).

Executed qualification of Tunnel Sterilizer, Clean-in-place (CIP), Steam-in-place (SIP).

Executed qualification activities of HVAC System and LAF Units.

Executed qualification activities of Utilities (Purified water Generation & Distribution system, WFI Generation & Distribution system, Pure Steam Generation & Distribution system, and Compressed Air Generation system).

Preparation and review of qualification closing reports.

Handling of Deviations & Change controls, and ensure the implementation of proposed changes.

Review of Batch preparation control records.

Supporting to RA department for dossier preparation and ANDA filing and involved in the preparation of APR’s

Involved in the execution and review of computer system validation (CSV) and SCADA.

RA Chem Pharma Limited, Hyderabad, India February 2012 - April 2013

Approved by USFDA, MHRA & Health Canada (TPD)

Executive - QA & Regulatory (Solid Oral Formulations)

Job summary:

In-Process Quality Assurance checks during dispensing, manufacturing and packaging activities and monitoring the online documentation.

Sampling of in-process and finished products samples during manufacturing & packaging.

Preparation and Review of SOPs related to IPQA.

Review of process Validation protocols, Reports and sampling protocols.

Involved in Cleaning Validation and Process Validation activities.

Performing documentation (Issuance of formats, BMR’s, BPR’s upon receiving a request from the concerned department).

Performing internal quality audits as per the approved internal quality audit schedule and tracking and monitoring of the Corrective and Preventive Actions.

Involved in the qualification & validation of Equipments.

Execution of validation activities and exhibit batches as per the approved protocol.

Preparation of Annual product review for Tablets and Pellets.

Review of ANDA batch records for Tablets and Capsules.

Involved in the Vendor Qualification (API & Excipients) documentation.

Handling of Deviations & Change controls and QMS activities.

Combat Drugs Limited, Hyderabad, India January 2011- January 2012

Approved by GMP

Production Executive (Solid Oral Formulations)

Job summary:

Monitoring the production activities for Tablets, Capsules and Liquids.

Monitoring the packing activities.

Preparation and review of BMR’s & BPR’s and performing online documentation.

Preparation and review of SOPs.

Audits Participated:

USFDA

MHRA

Customer audits (Mylan, Lupin, Novartis)

Computer Skills:

PGDCA in computers and good internet skills.

Personal Details:

Name T.G.P.CHANDRA SEKHAR

Father Name T.VENU GOPALA KRISHNA

Date of Birth 11 JULY 1987

Sex Male

Nationality Indian

Languages Known English, Hindi, Telugu.

Address for communication Flat no: 29, Aaditya Nagar,

Kukatpally, Hyderabad.

India.

Declaration

I hereby declare that the information furnished above is true to the best of my knowledge.

Place:

Date: T.G.P.CHANDRA SEKHAR

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