Saravanan is seeking a challenging position in quality assurance and regulatory affairs with his 7 years of experience in the pharmaceutical industry. He has expertise in validation activities including process, cleaning, and equipment qualification. His responsibilities have included handling cleaning and process validation protocols and batches, coordinating audits, issuing and archiving batch documents, and preparing quality review reports. He is proficient in computer systems and has experience working with regulatory agencies from various countries.

1. Saravanan.V
Ph: 91-9994883634 vasuvsaravanan@gmail.com
_____________________________________________________________
Objective:-
Desire a Challenging Position in Quality Assurance and Regulatory Affairs department and use
best of experience and knowledge to explore in pharma as a profession.
A highly talented and enthusiastic person with great deal of experience with Pharmaceutical Quality
Management Systems under a cGMP environment and other bench marking activities at pharmaceutical
companies.
Areas of Expertise & Experience:-
 Proven four years of diverse quality and technical knowledge experience.
 Extremely detail-oriented and organized.
 Handling of process validation batches and protocol
 Handling of cleaning validation batches and protocol
 Coordinating in validation activities of Dry heat, moist heat, HVAC, Water system, Vial
Washing M/C, Process, Cleaning and Kaye Validator Equipment.
 Reviewing of executed and master documents
 Preparation and reviewing of product Quality review report(PQR)
 Handled IPQA activities in Production department
 Equipment qualification in IQ,OQ , PQ
 Batch documents issuance, control and archival
 Coordinating in Media Fill activity and compilation
 Coordinating to external and internal Audits
 SOP generation and control and distribution
 Execution of commercial batches for US and other regulatory markets.
 Implementation of computer system validation throughout the plant by Gap assessment
of all GxP equipment.
 Familiar with 21 CFR part 211.68 and 21 CFR part 11& GAMP5
 Monitor effective implementation of the QMS by channelizing and routing issues
through system documentation procedures like Change controls, Deviations, Incident
reporting etc., and verification of CAPA taken as a compliance measure.

2. Audit Exposure:-
USFDA, MHRA, ANVISA, MCC, TGA, WHO, MOH of various regulatory bodies
Total Experienced : 7 Yrs 1 Month
Educational Qualification
Course detail University/college Year Completed
B Pharmacy
Nandha college of pharmacy
Erode (MGR university) 2008
PG Diploma in Quality Assurance
& Regulatory Affairs
Annamalai university 2014
Employment History:-
Mylan Laboratories Limited (Bangalore) Senior Associate-From July
2015 to till date.
Hospira Healthcare (Chennai) QA Executive– From Jan 2013 to July
2015.
Cipla Limited (Goa) QA officer – (From Oct 2009 to Jan 2013).
Star Drugs & Research Labs Ltd (Hosur) Production supervisor- (From
Feb 2009 to Aug 2009).
Experience summary:-
Job Profile:-
 Handlings of cleaning validation and protocol
 Handling of process validation batches and protocol
 Coordinating in Media fill activity and compilation
 Coordinating in internal as well as external Audits
 Issuing, controlling and archiving of batch documents
 Preparation and reviewing product Quality review report(PQR)
 Preparing and review of SOPs
 IPQA activities Production (Manufacturing Assurance and Filling aseptic Assurance).

3.  Coordinating in validation activities of Dry heat, moist heat, HVAC, Water system, Vial
Washing M/C, Process, Cleaning.
 Equipment qualification in IQ,OQ , PQ
Responsible for:-
 Handlings of cleaning validation and protocol, compilation report.
 Handling of process validation batches and protocol, compilation report.
 Coordinating with external departments for document compliance.
 Issuance and control of batch documents.
 Preparation and review of PQR.
 Reviewing of batch records
 Handling of in process Quality Assurance activities (Line Clearance, Sampling, Batch
record review CGMP compliances, assurance of product Quality by checking in
process parameter)
 Coordinating in internal Audits and External audits
 Ensure the technology transfers as per quality system
Personal details:-
Date of birth : 19th
Feb 1986
Marital status : Unmarried
Languages known : Tamil, English, Hindi, Marathi
Hobbies : Reading Books, Music collection, playing cricket
Father : Vasudevan.A.N
Occupation : Other
Mother : Kalaiyarshi.V
Permanent Address : S/O Vasudevan.A.N
1/50, Bajanai kovil street,
Rendadi (PO), Sholingur,
Vellore (DT),
Tamilnadu-631102
Computer Skills:-
 Production System Application
Generation of Master batch manufacturing and Master batch packing record and issuance of
Batch manufacturing record and batch packing record.
 Raw Material Creation Application
Generation of item codes for raw material and allocation of manufacturer code for
manufacturer.
 Packing material creation Application
Creation of bulk code to identify the bulk attributes of drug product and creation of pack code
to identify the pack attributes.
 WINDOWS 2007 & XP,MS-DOS
 MS-OFFICE, Internet.

4.  Documentum,my university training , Trackwise,
Strengths:-
 Positive attitude
 Sociable with Good Communication Skills
 Highly Industrious
 Responsible
 Hard working
 Believe in Team work
Field of Interest:-
 Quality Assurance, Regulatory affairs