This document provides an overview and resume for Kailas Narale, who has 24 years of experience in quality management for the pharmaceutical industry. The summary includes: - Experience in quality management roles for APIs, pharmaceutical formulations, biopharma, food additives, and nutraceuticals. - Current role as Head of Quality for VENKATESWARA HACHERIES Ltd, where responsibilities include implementation and monitoring of quality systems, audits, validations, regulatory compliance, training programs, and management reviews. - Education includes an M.Sc. and B.Sc. in chemistry from Shivaji University and additional training in areas like GMP, export management, and quality systems

1. kailas Narale
+91-9860363666 +91-80078795616 +91-20-24352883 kvnarale@gmail.com
OVERVIEW
24 years experience in Quality Management System in pharmaceutical industry ,Active Pharmaceuticals
Ingredients , Pharmaceutical Formulation Tablets, capsules, oral Liquid, injectable, Bulk pellets, poultry Vaccine , Bio-
pharma, Food additives, Nutraceuticals.Capacity. Directing work force to succeed in Total quality service and
corporate objectives, Ideas and vision while following policies, procedures and regulations; developing and
maintaining a professional management work environment; responding to clients requirements in a professional and
ethical business manner exceeding client expectations producing and delivering the highest quality product to
customer
PERSONAL DOSSIER
Date of Birth: 11th October 1961.
Postal Address: 9, Kshitij, Kudale -Patil, Survey No-53/2/1, Vadgaon B.K Pune -411041
Pass Port Number: E-3464222
Languages Known: Marathi, Hindi & English
JOB RESPNSIBILITY-QualityManagement System (QA/QC/RA)
1. Creation, approval and implementation of Corporate quality systems and procedures all site.
2. Responsible for review and approval of master documents (SOPs, Protocols, Batch Records, Specifications,
analytical records etc).
3. Release or rejection of raw materials, packaging materials, intermediates and finished goods.
4. Responsible for Validation /Calibration /Qualification equipments. Master validation plan.
5. Handling of customer Complaints, Vendor qualification.
6. Participate in investigation and approval Deviations, Change control, Out of specification (OOS) results
7. Management of change controls of products, process, test method, equipments and facilities.
8. Evaluation and investigation of customer complaints and corrective and preventive actions.
9. Approval of Participation in the review and revision of QC procedures, standard testing procedures, specifications,
method validation and cleaning validation.
10. Monitoring of updating standard test procedures as per Specifications.IP/BP/USP/EU /JP
11. Responsible for the implementation of cGMP and GLP systems. Training plan
12. Implementation of WHO GMP /EU GMP /USFDA/ICH and GLP the laboratory set-up/functions and up gradation of
laboratory systems as per the regulatory requirements.
13. Providing inputs and technical guidance on analytical methods. Review of Stability study ,
14. Monitoring for self inspections or quality audits for effectiveness and applicability of quality system.
15. Monitoring and approval of validation activities such as process validation, cleaning verification and validation and
analytical method validations.
16. Monitoring and approval of DQ/IQ/OQ/PQ, Qualification activities of equipment &instruments.
17. Monitoring and approval of calibration and preventive maintenance program for manufacturing equipment and
laboratory equipment and instruments.
18. Review and approval of Annual Product Review for all registered product.
19. Ensuring an appropriate training program is in place and executed.
20. Monitoring of stability and reserve sample program.
21. Investigation Complaints field alerts or product recalls and intimation of the same to management.
22. Management and final closure of internal and external audits. CAPA, compliance report to management
23. Participate in the all departmental budgets and procurement of same as per requirement.
24. Preparation and monitoring of production plan and actual production summary report.
25.To coordinate with all section Production Quality ,ware house engineering, R&D, Purchase, Marketing..
26. To participate in various International seminars & implementation of Quality Management Systems.
27.Vendor audit plan for input material and service provider ,Approved vendor list .
28. Health safety .Fire training ,mock inspection as per plan .IPQC/IPQC traceability documentation .
29. To approval of Quality, environmental policy/ safety policy implementation of QMS
30. Registration product various country, external customer regulatory audit and compliance report .
31. To verification quality input final product and spastically summary report to management for all product
32. To implementation Corporate quality policy to all manufacturing unit.
33. To conduct management review meeting summary report to management.
34. Attendance international seminar participate in presentation on QMS
35 .support to achieve target and Goal of top management by implementation QMS to all Units .

2. INDUSTRIAL TRAINING
• Member CHEM TECH FOUNDATION -Mumbai (2000 to 2005 ) ,
• Associated with CPHI /IDMA / PHARMEXCIL, Export promotion Organization. from 2005 .
• Pharmaceuticals Export – Import management by Dr. Lulla in INDO AMERICA SOCIATY Mumbai.
• Industrial Training conducted Anchrom – Mumbai practical application HPTLC / HPLC/ GC(2008)
• Application Water HPLC Identification Impurities profile at Bangalore -2000
• First award winner by Director NIPER on Lecture self life and stability of finished product Mohali – Aug 2008
• Pre qualification lead auditor for USFDA/EU-GMP/ WHO-GMP
• Quality management system HOD 100 % EOU, independent training plan for WHO GMP certification.
• Participation to promote product for CPHI from 2015 to 2010
• Certified GLOBAL GMP TRAINER & Auditor as Guideline of WHO cGMP.
• Quality management system training .NIPER Pharma /Bio tech Biological Product vaccine
• Implementation of GLP program held by FDA Pune.
• Practical training for 30 days Desktop Management- APTECH – 2001
EDUCATION & CREDENTIALS
• M.Sc (Phy- Chem) 1986 & B.Sc (Chemistry) 1984 Shivaji University .kohlapur.
• FDA Approved (Chem. Analysis & Instrumentation) FDA – THANE -1992
• Export & Import Management (Pharma) Indo America Society Mumbai – (2000).
• Desktop Management- APTECH .Corporate Quality management (2011)
• Certified Global GMP Trainer by INSIGHT INC.
Lead auditor for Pre-qualification Audit for WHO GMP / EU /USFDA Approval
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ACHIVEMENTS (1990 to 2014 )
 1990- Qualified for Certification of WHO GMP , API Export 80 tons per month API to UK /USA/Europe/Russia.
 1991- Cost reduction replacing solvent DMSO BY PSG for Trimethoprim ,approved product as per USP.grade.
 1992- Impurity reduced by methanol crude wash 1.8 % to 0.08,success to export 80 tons per month
 1993- Recycling of solvent LLP reduce 60 % saved solvent cost reduced for Norfloxacin/Cipfrofaxacine.
 1994- Qualified unit as of WHO –GMP Promote export 120 tons per month - pharmaceutical product of India
 1995- Unit certified WHO GMP, 50 tons USP grade material supplied to MNC and export to GermanyUSA.
 1996- GLP/ GMP, 25 lectures to all top manager to implement activity as WHO GMP Guideline , .
 1997- Export API Bulk drug to USA /Europe/ Russia /Canada/France export award
 1998- 100 % EOU High valve API molecules supplied to MNC ,export order execution to Europe
 1999- Contract manufacturing export order, API 80 ton export to USA.
 2000- Qualified Export –Import management in pharma at Indo – American society –Mumbai (2000)
 2001- Membership IDMA /Pharmaxicil ,Audit of unit for WHO GMP
 2002- Technical collaboration technology transfer .Boilogical poultry vaccine .
 2003- Export coordination with buyer technical support , outsourcing pharma
 2004- Management representative for ISO 90001 two years
 2005 –WHO GMP certification to Vamsi labs Ltd , Germany , supply cipla/Cadila High value API.
 2006 -CPHI exhibition participle in global market report division is developed business
 2007 - Approval certificate for WHO- GMP /EU GMP, success to export to Europe due EU GMP approval .
 2008- Pharmaxcil award received to organization Export of pellet to UK/USA/ Australian.
 2009- WHO GMP Certification Approval for unit 100 % EOU.
 2010- success contact to supply to Mylan USA – contract manufacturing Omeprozol pellets 10 ton /month
 2011- Venkatewara Hacheries Ltd Joined Sr. Manager Quality Assurance implementation of QMS
 2012-Seminar IDMA Golden Jubilee Participate with officer of EU/USFDA/WHO /IDMA.
 2013- Training on GMP / GLP to production quality staff ,preparation ISO 9001 /Audit WHO GMP
 2014 Received Certified as ISO 9001-2008. Charge Head Of Quality assurance
PRACTICAL EXPERIENCE (1986-2015)
Name of Organization Designation Company
Profile
Duration REPORT
1) Metox Fine chemical P ltd-Pune QA/Q.C- officer API100 % EOU 18/12/1986 -6/02/1992 VP QA
2) The PharmaceuticalProduct of India Manager Q.A. API /Bio Pharma 13/4/1992 -10/02/1995 Director -
3) Tasc PharmaceuticalLtd-Mumbai Head - Q.A. 100% EOU API, 15/02/1995 - 02/04/1998 CMD
4) Supriya Chemicals Pvt. Ltd-Mumbai Sr. Manager .Q.A. 100% EOU API 7/04/1998 -1/12/2000 MD
4) Sigma Laboratories Ltd-Mumbai Manager Q.A. BiologicalProduct 11/12/2000 -18/08/2004 CMD
5) Vamsi Labs Ltd.-Solapur MR - ISO
Sr. Manager Q.A.
Bulk .Formulation 10/12/2005 - 18/12/2007 MD
6) Murali Krishna Pharma Pvt. Ltd. Sr. Manager Q.A. Pellets.Export 22/01/2008 -12/12/2010 MD.
7) Concord Bio Tech LTD Ahmadabad Sr. Manager -QA Bio Tech .Vaccine 21/12/2010 - 26/02/2011 Director
8) VENKATESWARA HACHERIES Ltd
VENTRI Biological vaccine Division.
Head-Quality
Sr. Manager Q.A.
Live virus /
Poultry vaccine
01/03/2011 – working MD