Project Manager Quality Assurance

Kedar Gajanan Lalit

***/***, ********** *********,

Gangasagar complex,

Shivganganagar,

Ambernath (E), Thane 421501

Email: - ***********@**********.***

Contact: - 976-***-****.

Professional Summary

• Experience: Around 16 years of experience of working in Chemical, pharmaceutical industries. Some Highlights include:

• Recently working again with m/s GJJ business solutions, South Africa as a technical consultant since May’2012 till date.

• Worked with Abhinandan Rasayan Pvt.Ltd, Taloja as “Quality Assurance Manager” since June 2010 to Apr 2012. The organization is a part of group of companies under Abhinandan laboratories & engaged in manufacturing of API’s & intermediates. Handling all QA related activity and QC related activity.

• Worked with Medigraph Pharmaceuticals pvt.ltd.,Taloja As “Quality Assurance Manager” From June’2009 to Jan’2010.The organization was a part of group of companies under sanvin laboratories & engaged in manufacturing of API’s(Narcotics) & intermediates. Handling all QA related activity.

• worked with GJJ Business Solutions, South Africa as an project manager from June’2007 to march’2009. The organization is engaged in manufacturing bulk drugs & intermediates.

• Aarti industries ltd, Dombivli worked as a Sr.Quality assurance officer. The organization is ISO & USFDA approved engaged in manufacturing bulk drugs & intermediates.

• Sekhsaria chemicals ltd,Dombivli worked as a Quality control officer as senior from mar’2005 to feb’2007.Managing various projects including audit presentation of ISO,USFDA,FDA etc and Analysis of RM,In-process and finished products with preparation of documentation for the same. The organization is USFDA approved engaged in manufacturing bulk drugs & intermediates, formulation.

• Nearly Three years with Thomas Baker chemicals ltd, Ambernath worked as “Assistant manager, Quality control” from mar’2002 to feb’2005.Managing all activities of QC. The organization is engaged in manufacturing industrial chemicals, fine chemicals, cosmetics.

• Nearly five years with Aromatic & industrial chemicals (p) ltd, Ambernath worked as an ‘Sr Analytical chemist’ in quality control from june’1997 to jan’2002. The organization is ISO approved engaged in manufacturing bulk drugs & intermediates, industrial chemicals.

Education

• Bachelor of science, Mumbai University

• Appeared Master of business administration appeared third year,YCMOU,Pune

• Persuing M.Sc.From Mumbai university

Technical Skills

Presentations: Internal & external Audits

General management: Can handle more than one unit at a time.

Basic software’s: ms office,

Proficiency in instruments: Gas chromatograph (manual,autosampler,packed & capillary columns) of netel,fission-8000,agilent-6890,shimadzu ; HPLC (manual,autoinjector) of spectra system SPD-10A,shimadz ; Polarimeter (digital, manual); Autotitrator(labindia); potentiometer; polarograph; UV-VIS spectrophotometer ; FTIR,PH meter ; viscometer etc

Special skills/abilities

• Good management skills

• Good listener, organizer

• Good communication skills

Hobbies

• Classical music

• Paintings, Reading,

Professional Experience

• Company Name : Abhinandan Rasayan Pvt.Ltd. June 2010 till date

Designation: Quality Assurance Manager.

Contribution: Handling two units of the group (one At Taloja and one at Ambernath) for various organizational activities & documentation control and Quality Control department. Approving all Specifications, Standard Test Procedures (STPs), and Batch Manufacturing Records (BMRs), Approving changes, Reviewing and approving validation protocols and reports, Reviewing completed Batch Manufacturing Records (BMRs) and analytical records for critical process steps before release of the API for sale, investigate and closure of critical deviations, ensure that materials are appropriately tested and results are reported, Release of APIs for sale, investigate and resolve quality related customer complaints, Conducting Self-Inspections, Authority and Customer audit compliances, Vendor qualification and vendor audits, Approving intermediates and API contract manufacturers Performing annual product quality reviews. Preparation and control of SMF, MFR, DMF, BMR, ECR, Technology Transfer Documents, and Validations documents etc. Preparation and implementation of SOP’s.

• Company Name : Medigraph Pharmaceuticals Pvt.Ltd. June 2009 till date

Designation : Quality Assurance Manager.

Contribution : Handled three units of the group (two At Taloja and one at Badlapur) for various organizational activities & documentation control and Quality Control department. Approving all Specifications, Standard Test Procedures (STPs), and Batch Manufacturing Records (BMRs), Approving changes, Reviewing and approving validation protocols and reports, Reviewing completed Batch Manufacturing Records (BMRs) and analytical records for critical process steps before release of the API for sale, investigate and closure of critical deviations, ensure that materials are appropriately tested and results are reported, Release of APIs for sale, investigate and resolve quality related customer complaints, Conducting Self-Inspections, Authority and Customer audit compliances, Vendor qualification and vendor audits, Approving intermediates and API contract manufacturers Performing annual product quality reviews. Preparation and control of SMF, MFR, DMF, BMR, ECR, Technology Transfer Documents, and Validations documents etc. Preparation and implementation of SOP’s.

• Company Name: GJJ Business solutions June2007 to march 2009

Designation : Project manager

Contribution

Worked as project manager for various organizational activities & documentation such as,preparation of products,preparation of master formula,technology development,monitoring quality & stability,preparation of batch process records,specification review,quality audits & quality assurance activity.

• Company Name: Aarti industries ltd. March 2007 to may 2007

Designation: Sr.QA officer

Contribution

Worked as a Sr.QA Officer handling QA related documents such as,Preparation of annual product review,preparation of master formula card,technology transfer document,monitoring stability study,preparation of batch process record,specification review,quality audits& QA rounds to QC,ADL,R&D.

• Company Name: Sekhsaria Chemicals Ltd march 2005 to feb 2007

Designation: Quality Control Officer

Contribution

Giving training to new comer chemists,calibrations of GC,trend analysis,working in finished goods & inprocess section,validation & QA documentation.

• Company Name: Thomas Baker chemicals Ltd Feb 2002 to mar 2005

Designation: Quality Control assistant manager

Contribution

Designing of department work,signing of reports & certificates of analysis,attending of management meetings,facing audits (like departmental,customer,ISO,FDA)as auditee,conducting audits for departments & vendors,complaint attendences for customers,conducting interviews,general management in QC.

• Company Name: Aromatic & Indl.chemicals (P) ltd July 1997 to feb2002

Designation: Sr.analytical chemist

Contribution

Company is the Quality control division of EMERCK(I)ltd.

Worked for general chemicals,calibration of instruments,mentainence of instruments & equipments,preparing SOP’s of products,training of juniors,acetic anhydride & potassium cyanide stock mentainence,signing of reports in absence of QC manager,procurement of chemicals & reagents for lab purpose,help in R&D for development.

Languages known : Marathi, Hindi, English

Passport No : F1438640

Salary : 8.00 lacs p.a.CTC (Last March 2012 in India)

Place : Ambernath Kedar Gajanan Lalit

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