CURRICULUM VITAE
e-mail :
mobile: +91 9673880155/9538964448

SIDDHARTH SATYAWAN NAIK

R/o Flat number C209

R1 – Apartment,

Vakil Whispering Woods, Thirumagondanahalli,

Madiwala Village, Anekal Taluka

Bengaluru, Karnataka -562106, INDIA

Mobile: +91 9673880155

To,

Human Resources Department

I am seeking an opportunity in your organization befitting my professional experience, educational background and skills.

My education includes a M.Sc.(chemistry) concerning my professional experience; I am currently employed in reputed pharmaceutical companies with about 19 years of cross-functional exposure. During which I have gained valuable experience in department such as Quality control, Quality Assurance and Product Evaluation & Analytical Support(Exhibit Stability).

I am having good knowledge and expertise on 21 CFR and data integrity guidance. Having capabilities to ensure the compliance of written procedures in routine working, gap analysis and implementation of improved quality system to ensure the overall compliance in Laboratory i.e. continuous evaluation of Quality systems.

I believe my broad-based cross-functional exposure and skills make me an excellent candidature to consider for an opportunity in your respected organization.

Enclosed is a curriculum vitae that provides more details about my background and qualifications. I am confident that I possess all the necessary qualifications and I am ready to meet with your concerned personnel at their convenience.

I look forward to hearing from your organisation.

Sincerely yours,

Siddharth S Naik Encl: CURRICULUM VITAE

Objective:

To Serve the organization by diligent work, with proper group synchronization and simultaneously add value to one self and focus on quality and timely execution of the assigned job.

Pharmaceutical Industry Experience: (19 Years)

Working as ‘Group Leader’ in Pharmaceutical Product Evaluation & Analytical Support department (Exhibit Stability) at Apotex Research Private Limited, Bangalore from Apr 2016 to till date.

Job description:

·  Presently leading Investigation Team and Documentation Team along with Team involved in Shelf life evaluation of Zone IV market products in product evaluation and analytical support department (Exhibit stability-PE&AS).

·  Responsible for Investigation and evaluation of Deviations, CAPA, Change control, Incidences through QMS trackwise and OOS and OOT through Labware LIMS related to PE&AS department.

·  To ensure shelf life evaluation of pre-marketed Zone IV stability projects for regulatory submissions.

·  To review and approve various documents like standard operating procedures, change controls and investigations.

·  To impart training of technical, SOP as well as principles of GLP and GMP to employees as a qualified trainer.

·  Handling of regulatory as well as internal audits & ensuring timely compliance to the audit observations if any.

·  Planning, overall monitoring, trouble shooting and co-ordination with other departments for smooth functioning of laboratory.

Worked as ‘Assistant Manager-QC’ in Glenmark Pharmaceuticals Ltd., Goa since Dec 2012 to Apr 2016.

Job description:

·  Leading Raw material section.

·  Responsible for managing routine QC activities related to Raw Material testing and release.

·  Responsible for Analytical Method Transfer and Method Verification related to Raw Material.

·  Handling of Deviations, change control, Incidences, OOS and OOT and Regulatory Affairs Queries.

·  Usage decision in SAP for raw material release.

·  Training analyst regarding quality systems as per cGMP standards and HPLC trouble shooting, Good Laboratory Practices, all time readiness and data integrity.

·  Successfully completed project of performing method feasibility for test carried out at external lab (Performed method feasibility 50 tests of active and excipients by AAS, HPLC and chemical method by procuring the requirements like reference standards, chemicals, HPLC columns etc.).

·  Review of pharmacopoeia changes updates.

·  Preparation of regulatory audits like US FDA,MHRA,WHO.

Worked as ‘Senior Executive QC and QA’ in Lupin Limited, Goa since Oct 2007 to Dec 2012.

Job description:

·  Worked as a Team Leader in exhibit stability section in Lupin Limited,Goa.

·  Handling Deviations, change control, OOS and incidences.

·  Review of Analytical Reports.

·  Handling of regulatory affairs queries and technology transfer of products.

·  Imparting training to analyst regarding SOP and HPLC trouble shooting.

·  Preparation of regulatory audits like US FDA, MHRA, WHO.

(As a Sr. Executive QA) - worked in QA department and handled group of documentation (Spec/STP preparation and implementation) and documentation cell since Dec 2011 to Dec 2012.

Worked as ‘Sr.Officer-QC’ in Geno Pharmaceuticals Ltd, Goa since Oct 2003 to Oct 2007.

Job description:

·  Analysis of Assay, Related substances and Dissolution tests for finished and semi-finished

product by using HPLC.

·  Microbiological testing of Water, Raw materials and Finished products.

·  Maintaining working standard, reference standard and primary standards.

·  Preparation of process validation protocols (worked as a validation team member).

·  Worked as a section head of finished product and stability section.

Worked as ‘Officer-QC’ in Bevit Pharmaceuticals LTD, Goa since Jul 2002 to Oct 2003.

Job description:

  • Sampling and Analysis of various active and non-active raw materials.
  • Sampling and Analysis of various Packing materials.
  • Sampling and Analysis of Purified Water.
  • Analysis of semi-finished and finished products.
  • Microbiological testing of Water, Raw materials and Finished products.

Worked as ‘Chemist-QC’ in Blossom Pharmaceuticals, Goa since Jun 1999 to Jul 2002.

Job description:

  • Sampling and Analysis of various active and non-active raw materials.
  • Sampling and Analysis of various Packing materials.
  • Sampling and Analysis of Purified Water.
  • Analysis of semi-finished and finished products.
  • Done IPQC checking.
  • Microbiological testing of Water, Raw materials and Finished products.

Worked as ‘Chemist-QC’ in Goa Antibiotics and pharmaceuticals Ltd, Goa since Dec 1997 to Jun 1999.

Job description:

·  Sampling and Analysis of various active and non-active raw materials

·  Sampling and Analysis of various Packing materials

·  Sampling and Analysis of Purified Water.

·  Analysis of semi-finished and finished products

·  Done IPQC checking

·  Audit exposure: USFDA,MHRA, TGA and WHO

Academic Credentials:

Education / Name of the institute / Year of passing
SSC / Dnyan prassarak high schoool,Mapusa - Goa / 1991
HSSC / St.Xavier higher secondary school, Mapusa- Goa. / 1993
BSc (Chemistry) / St.Xaviers college, Mapusa-Goa. / 1996
MSc (Chemistry) / Kuvempu University, Shimoga-Karnataka. / 2007

INSTRUMENTS EXPOSURE:

·  HPLC (Waters-empower3, Shimadzu & Dionex.)

·  Dissolution test apparatus (Electrolab, Distek)

·  FTIR & UV spectrophotometer (Shimadzu)

·  Auto-Titrator and KF-Titrator

·  GC (Shimadzu & Perkin Elmer)

PERSONAL DETAILS
Name / Siddharth S Naik
Nationality / Indian
Fathers Name / Satyawan Gunaji Naik
Martial Status / Married
Date of Birth / 15-07-1975
Religion / Hindu
Sex / Male
Language Skills / Hindi, English, Marathi and Konkani
Approvals / Approved in Chemical and Instrumentational Analysis by Goa FDA
Approved in Microbiological Testing by Goa FDA
Permanent address /

R/o House No. 256

Gaonkarwada, Tuyem,
Pernem-Goa
Pin- 403512
Mobile: +91 9673880155

REFERENCE: Asim Shroti ( Lupin Research Park, Pune-Maharashtra)

Mob : 9860620392

Anand Kambli ( Sr.Manager Analytical Operations-Apotex, Bangalore.)

Mob: 9822124616

DECLARATION:

I hereby declare that the information furnished above in this resume is true to the best of my knowledge and belief.

PLACE:

DATE: (Siddharth S Naik)