RESUME

Mr. Eknath Nabhiraj Katkar

PROFESSIONAL QUALIFICATION

B. Pharma from P.D.V.V. P. College of Pharmacy, Ahmednagar, in 1999 with First class (62.58%), Pune University (Maharashtra).

ACADEMIC QUALIFICATION

HSC from Residential Junior College, Ahmednagar, in 1995 with First class (63.50%), Maharashtra State Board Pune.

SSC from Jawahar Vidyalaya, Majalgaon, Dist. Beed, in 1993 with First class (73.85%), Maharashtra State Board Pune.

PROFESSIONAL EXPERIENCE

Current Employer : B. V. Bio-Corp Pvt Limited,

(A Division of Venky’s Nutrition)

Human Healthcare Products Division,

S. No. S-346, Village - Morwadi, Post - Kikwi,

Tal.- Bhor, Dist. - Pune 412 206.

Duration : From Jan. 2015 to Dec 2016.

Designation : Dy. Manager - Production

PREVIOUS EMPLOYERS

1.Employer : Shilpa Medicare Limited

Unit-IV, Pharma SEZ, APIIC,

Jadcherla, Dist. Mahbubnagar, AP.

Duration : From Nov. 2013 to Feb 2014.

Designation : Executive - Production

2.Employer : Merck Serono India

Duration : From Nov. 2007 to Jul 2013.

Designation : Executive - Quality Assurance (Contract Manufacturing)

3.Employer : Ajanta Pharma Limited, Chikalthana, Dist. Aurangabad.

Duration : From Sep. 2006 to Oct. 2007.

Designation : Officer - Production (Liquid/ Capsule/Tablet).

4.Employer : Flamingo Pharmaceuticals Limited, Taloja, Dist. Raigad.

Duration : From Aug. 2005 to Aug. 2006.

Designation : Officer - Production (Tablet/Capsule).

5.Employer : FDC Limited, B-8, M.I.D.C., Waluj, Dist. Aurangabad.

Duration : From Feb. 2000 to Apr. 2005.

Designation : Officer - Production Liquid / Powder (Oral and External).

WORK EXPERIENCE IN BRIEF

1.Employer : B. V. Bio-Corp Pvt. Limited

Responsibilities:

1.To prepare and Review the monthly Production Plan.

2.Daily, Weekly and Monthly Planning of Production.

3.To Plan the daily and weekly Dispensing of Raw material and Packing

Material as per the production schedule.

4.To conduct Online Training Program for Temporary and Permanent Workmen

5.To prepare WIP and Performance Report, monthly.

6.Review and Update Batch Manufacturing Record, Standard Operating Procedures for New process/New product/New Equipment or any other changes.

7.To Plan and carry out Preventive Maintenance of Machines and Manufacturing equipments.

8.Responsible for monitoring and control of day to day operations of production, packing and store.

9.To guide and help the team for troubleshooting if any.

10.Preparation and Review of BMR, BPR.

11.Coordination with internal departments like Marketing, engineering services,

Utility Department, purchase department, QA and QC department to get the

work done.

12.Maintaining overall cGMP in all operations.

13.To raise indents for Raw Material, Packing Material, Miscellaneous Material, other consumables and required equipments.

14.Part of Quality and cGMP audit by internal and external agencies and the compliances for same.

15.Part of team for review of documents related to regulatory submission.

16.Ensure that the production goals and targets are achieved within defined time.

17.To study the processes and recommend measures to cut cost of manufacturing.

18.Should be a part of the audits and keep the department under total cGMP

Compliance.

19.To confirm the on line ERP Entries by the team.

2.Employer : Shilpa Medicare Limited.

Responsibilities:

1.Scheduling the production and packing activities as per the requirement.

2.Responsible for monitoring and control of day to day operations of production and packing.

3.Preparation and Review of BMR, BPR, qualification documents, validation protocols and validation reports.

4.Coordination with service departments like engineering services, utility department, purchase department, QA and QC department to get the work done.

5.Maintaining overall cGMP in all operations.

6.To raise indents for the monthly consumables.

7.Part of Quality and cGMP audit by internal and external agencies and the compliances for same.

8.Part of team for review of documents related to regulatory submission.

9.Ensure that the production goals and targets are achieved within defined time.

10.To study the processes and recommend measures to cut cost of manufacturing.

11.Should be a part of the audits and keep the department under total cGMP compliance.

12.Responsible for on line ERP Entries.

3.Employer : Merck Serono India.

Responsibilities:

1.To ensure that all manufacturing, packing operations carried out at Contract Manufacturing site are in compliance to current good manufacturing practices.

2.To ensure that the testing carried out at the Contract Manufacturing site laboratories are in compliance to Good Laboratory Practices.

3.To ensure that all documents are created, revised, identified, approved, issued, distributed, retrieved and disposed as per Good Documentation practices complying to corporate policies and local Regulatory requirements.

4.To ensure that all concerned employees are trained before the new or revised document is implemented. Whenever required to give proper training to the Personnel’s of Contract manufacturing site for cGMP Practices and Merck’s Requirement of Quality Products.

5.Review of the documents like Master manufacturing Records, Batch Records, (of the export and domestic product) and SOPs, Validation documents, like URS, Qualification protocols, and Process Validation Protocols and Cleaning validation protocols.

6.To ensure that all Changes at Contract Manufacturing site related to products and Critical systems are managed through Change Control system and assessed for its impact, scientifically executed and closed in compliance the Regulatory and Corporate requirements.

7.To ensure that all deviations and Non Conformances at Contract Manufacturing site related to products and Critical systems are suitably, scientifically and logically handled, documented, investigated for root cause, assessed for its impact on Product Quality and Safety.

8.To ensure that appropriate Corrective actions are taken to mitigate the effect of deviation or nonconformance on the Product and Preventive actions are taken to mitigate the recurrence in future.

9.To carry routine quality rounds at the Contract Manufacturing site, documentation reviews to ensure compliance.

10.To report the audit finding to the Corporate QA and Top Management of Contract Manufacturing site and recommend appropriate Corrective and Preventive actions to close the findings.

11.Verification of control sample and its record of every manufacturing batch before releasing product to market.

12.Review of batch manufacturing and packing records, QC documents like raw and packaging materials analysis, bulk and finished product analysis reports, microbial raw data and results, and releasing product to dispatch.

13.To ensure that the Products are released and dispatched only after complete documentation review.

14.Attend on-line problems of raw and packing materials and ensuring quality supply from suppliers.

15.Co-ordination of validation activity at location to fulfill regulatory guidelines and requirements.

16.To ensure that a CAPA plan is designed, agreed and approved to comply the findings noticed during any Regulatory audit, Internal Quality audit or any other audit.

17.To ensure that the CAPA is implemented timely, tracked for its completion, monitor its effectiveness, modify if required and close it.

18.To ensure that latest updated approved artworks are used for analysis and release of the Printed Packaging Material. To ensure that the obsolete Artworks are properly handled as per SOP.

19.To help the Corporate Packaging Development Department for developing the artwork specifically for machine trials, OPZ Area and user suitability.

20.To ensure that the products are manufactured and released timely as per GMP to the markets to ensure continuous supply of the product.

21.To ensure that products are properly stored in Finished Goods Store.

22.To find out the root cause for the complaints received, investigate with proper preventive action. To designing CAPA in association with the Contract Manufacturing site to mitigate the market complaints.

23.To Support the technology transfer, validation work and launch for new products at Contract Manufacturing site as per Guidelines.

24.To support for the Qualification of Pharmaceutical equipments.

25.To Collect, Compile the Trend data for preparation of APQR and forwarding the same to Corporate QA in the given Excel sheet format.

26.To report the compiled Quality Issues to the Corporate QA in monthly Report.

27.Routine inspection for various departments to maintain GMP Compliance at all levels.

28.Monitoring and conducting various in process checks like Line Clearance, Equipment clearance, in process testing and online documentation at Contract Manufacturing site.

29.Carry out rounds in QC and Microbiology to verify GLP practices and online documentation.

30.To support R & D activity, related with new product or any vendor development trails at the site. Vendor development raw material / packing material analysis and related trials at site to take decision for commercial supply and vendor approval.

31.Provide the Finished Product COAs as and when required for Export/Govt. supply Batches. Also to provide the RM/PM COAs whenever required for registration purpose.

32.To review audit compliance in the facility.

33.Random checking of the finished goods for Quality and other requirements as per Merck’s Guide Lines.

34.To check and confirm for Implementation of the Revised Price and the changes in the specifications of the Raw Materials and Packing Materials.

35.Trouble shooting in formulations at various manufacturing / packing /analysis stages.

36.Proper checks on the daily activities so as to avoid the deviations in the process or documents. Communication for approval of Deviations (if any) and the Change controls.

3 Employer : Ajanta Pharma Limited.

Responsibilities:

1.Ensure delivery of quality production on time as instructed by the Assistant Production Manager.

2.To assist Assistant Production Manager in documenting.

3.Raising work order in case of any breakdown of machinery / equipment.

4.Ensure accurate and timely record maintenance, retrieval and submission of MIS to superiors and cross-functional as requested.

5.Implementation of all systems as laid by Assistant Production Manager.

6.Ensure all procedures, policies are thoroughly understood by subordinates and Permanent and temporary workmen.

7.Provide ongoing support to all other functions / departments to ensure smooth functioning of workflow.

8.Directing and supervising activities of subordinates.

9.Review and Update Standard Operating Procedures for New process/New

Product/New Equipment or any other changes.

4Employer : Flamingo Pharmaceuticals Limited.

Responsibilities:

1.Supervision of Manufacturing, Granulation, Compression and Coating of Tablets and Capsule Manufacturing and Filling etc. to maintain desired quality standards of the product.

2.Proper Manpower allocation and Utilization.

3.Online Documentation - Batch manufacturing Record, GMP Books etc.

4.To Plan and carry out issue of raw material as per requirement.

5.To conduct Online Training Program for Temporary and Permanent Workmen.

6.To assist Assistant Production Manager in documenting.

7.Implementation of all systems as laid by Assistant Production Manager.

8.Ensure all procedures, policies are thoroughly understood by subordinates and Permanent and Temporary workmen.

9.Provide ongoing support to all other functions / departments to ensure smooth functioning of workflow.

10.Review and Update Standard Operating Procedures for New process/New product/New Equipment or any other changes.

5Employer : FDC Limited.

Responsibilities:

1.Supervision of Manufacturing, Filling and Packing etc. to maintain desired quality standards of the product.

2.Proper Manpower allocation and Utilization.

3.Online Documentation - Batch manufacturing Record, GMP Books etc.

4.To Plan and carry out issue/Dispensing of Raw material and Packing

Material as per requirement.

5.To conduct Online Training Program for Temporary and Permanent Workmen.

6.To confirm availability of Stereos, Stamps, Sticker Labels, Overprinted Material and Shipper Labels.

7.Preparation and Review of Loading Chart as per Production Plan, Marketing

8.Requirement and Export Requirement and to take corrective action if any.

9.Daily, Weekly and Monthly Planning of Production.

10.To prepare WIP and Performance Report, monthly.

11.Review and Update Master Formula Record, Batch Manufacturing Record, Standard Operating Procedures for New process/New product/New Equipment or any other changes.

12.To Plan and carry out Preventive Maintenance of Machines and Manufacturing Tanks and to update Preventive Maintenance Schedule.

13.Preparation of protocol and Simultaneous Execution of Design Qualification,

14.Installation Qualification, Operation Qualification, Performance

15.Qualification, Process Validation, Tank Calibration, Annual Product Review.

COMPUTER AND OTHER SKILLS

Operating Knowledge of Computer (MS OFFICE).

Knowledge of Net Surfing.

Written and Oral communication.

PERSONAL PROFILE

Birth Date : 10 August 1978

Marital Status : Married.

Languages known : Hindi, Marathi, English.

Contact : 832-***-**** OR 982-***-****

E-mail I. D. : acz1wy@r.postjobfree.com OR acz1wy@r.postjobfree.com

Address : C/O U.D. Potdar

N-4, B-20/B, (First Floor),

CIDCO, Aurangabad 431003.

Contact this candidate