Siddharth V. Patel

MBA (Finance)

M.Pharm. (Pharmaceutical Biotechnology) 53, Hans Society, Varachha Road, Surat - 395006. (Hometown) (M): +91 – 8469244699; E-mail: export@elecorepharma.com, info@elecorepharma.com Date of Birth: Dec 26, 1987 Total Experiance: 5 years

Current Job Profile:

Designation at BIOGEN Pharmaceutical Co.: Asst. General Manager.

Designation at Globela Pharma:

In-charge, Regulatory Affairs and

Production Executive (Approved Technical Person in Capsule Sep 2013).

(Working Under Loan Licence & Third Party Manufacturing)

Exposure to Areas of manufacturing:

1. Tablets

a. Film / Enteric / Sugar Coated,

b. Uncoated, Mouth Dissolving, Dispersible and Chewable,

2. Capsules (Hard Gelatine Capsules only – Pellet / Powder filling),

3. Direct Compressible Granules,

4. Suspension (To be reconstituted before use – Dry preparation only),

5. ORS (Oral Rehydration Salts),

Exposure to Categories of Finished Product:

1. Oncology Products (Anti-cancer),

2. ORS (WHO recommended Oral Rehydration Salts),

3. Anti-asthmatic/ Anti-allergic,

4. Multivitamin and Minerals, OTC Medicine,

5. Antibiotics, Anti-diabetics,

6. Controlled Release Medicine,

7. Multipurpose Tablets (With Multiple API’s),

8. Therapeutic KITs and

9. Non-steroidal Analgesics / Antipyretics.

Performance / Job Responsibilities APART FROM PRODUCTION

To prepare and maintain –

1. Training of new employees for their responsibilities (especially fresher),

2. Manufacturing Master Card/ Master Formula Record preparation and Review,

3. Batch Manufacturing Record & Batch Packing Record preparation and Review,

4. Executing Process Validation of Prospective &Concurrent Batches (Inhouse & ICH Format),

5. Sampling of Raw Materials, Bulk Drug, Semi-finished Product & Finished product,

6. Calibration of Analytical instruments,

7. HPLC column maintenance / regeneration,

8. Analytical Method Development& Validation for Inhouse Method of Analysis &

9. Performing Stability Studies and monitoring Stability Chambers,

10. Preparation and authorisation of working Standard and Review,

11. Deviation Record and Change Control and Review,

12. Maintaining Sanitisation of class I (100,000 CFU) and Class II (10,000 CFU) area,

13. Maintaining Cleaning of Oncology Department by Robust Swab Test Method,

14. Maintaining Quality of the Purified Water at Inhouse Purified Water Plant,

15. Validating HVAC System,

16. Maintaining Air lock system (bubble) in production Area,

17. LAF – Laminar Air Flow and RLAF – Reverse Laminar Air Flow Monitoring &Validation,

18. Prepare & Review New SOPs and releasing Controlled copy to respective department Head,

19. Computer Training and Employee Development with Employee Technical Feedback,

20. Monitoring and controlling Destruction of Waste Material,

21. In-process Quality Control and In-process Quality Control Training,

22. Preparing and monitoring Retest and Internal Audit Schedule and Review Execution,

23. Training on WHO GMP – Good Manufacturing Practice and GLP – Good Laboratory

Practice,

24. Training on Minimising Manual / Personnel Errors,

25. Intermediate Technical Performance Appraisal,

26. Dossier Preparation: ACTD/ CTD/ Non-CTD Format. (More frequently ACTD Format) &

27. Review and Approval of Raw Material and Finished Product Specifications as per official

text / predefined Inhouse Standard.

Instrumental Exposure:

I can train employees for Operating, Calibrating and Validating below mentioned instruments:

o Centrifuge,

o PCR Instrument (Polymerase Chain Reaction Instrument),

o Gel Electrophoresis with cooling jacket and double plating, Isocratic and Gradient systems,

o Gel Documentation Unit with light focussing and band labelling facility against molecular weight

Ladder,

o Fermenter, Autoclave, Infra-Red Spectrophotometer for solid samples,

o UV- VIS. Spectrophotometer (Non-derivative method only),

o HPTLC, operated for method development and fingerprinting,

o GC, operated for method development and fingerprinting,

o HPLC, operated for method development and fingerprinting, o ELISA reader, Potentiometer, Calorimeter, Dissolution Apparatus, pH Meter,

o Disintegration Apparatus, Leak Test Apparatus, Friability Apparatus, and a lot more …

Analytical and Method Development Training:

1. One month Extensive Training in QC Department at

ZYDUS CADILA, (Unit-3, API Division, Ankleshwar);

as Technical Expert under supervision of Deputy General Manager, Mr. Rakesh Khopkar and

Executive Manager Quality Control, Mr. Ashish Patel in NOV 2007.

2. 8 months of Exclusive R & D work (F&D, in-fact) as Industrial Project

On enzyme formulation and Biocatalysis/ Biotransformation resulting into Chiral Seperation

of the molecule of interest at

HITECH BIO SCIENCE PVT. LTD. (HTBI Group of Industries)

R&D Lab, Sutarwadi, Pune, INDIA.

under supervision of Dr. Chetan Shah (Research Scientist), Dr. Wangikar (Guest Research

Scientist, from IIT) and Ms. Sushma Kurhade (Department Head, R&D – Protein Chemistry).

Industrial Exposure:

1. Approved Production Chemist and In-charge, Regulatory Affairs at

GLOBELA PHARMA PVT. LTD.

357, Road No. 3, GIDC,

Sachin, Surat – 294 230.

GUJARAT, INDIA.

2. Currently working as Asst. GM at

BIOGEN Pharmaceutical Co.

165 to 169, Patel Industrial Estate,

Delad Patiya, Sayan,

Tal.: Olpad, Dist.: Surat,

Gujarat, INDIA.

Future Planning:

Working with your organization for more than 2 years with higher designation and compensation.

Educational Qualification:

Qualification Institution Board/ University

Year of passing

% or *CGPA In Final Passing Exam

MBA (Finance) Distance Mode

Sikkim Manipal University, NIFEM, Pune.

SMU 2013 A Grade

(72%)

M.Pharm (Pharm. Biotech)

School of Pharmacy and Technology Management,

NMIMS, Mumbai.

NMIMS Mumbai

2011 A+

(3.32*/4)

B.Pharm Padm. Dr. D. Y. Patil I. P. S. R. Pimpri, Pune.

Pune University

2009 59.08%

H.S.C Shree P. P. Savani Vidhyabhavan, Surat.

G.S.H.E.B. 2005 62.15%

S.S.C Shree Ramkrishna Vidhyabhavan, Surat.

G.S.H.E.B. 2003 87.29%

*Cumulative Grade Point Average.

Above mentioned information is fair and correct as per my knowledge and all the original documents

will be presented when required.

Siddharth Patel Ex. AGM, BIOGEN Pharmaceutical Co.