Ashish Tyagi Correspondence Address:
ØTo improve and sharpen my knowledge and skills, within an established organization where my dedication and hard work will gain me a position of substantial responsibility.
ØCurrently working as Executive-QA with Alkem laboratories Ltd. Ankleshwar, Gujarat (USFDA, TGA Approved) since December 2015 to till date.
ØEight months working with Unimark remedies limited (USFDA approved), Vapi, Gujrat.
Ø4 year 06 months experience in quality assurance department with Ind-Swift Laboratories Ltd, Dera basi, Mohali, Punjab (USFDA approved) from Oct 2010 to March 2015.
ØPreparation and review of Annual Product Quality Review.
ØHandling of process validation activity:
Preparation and review of Process validation Protocol/Report, Cleaning validation Protocol/Report, Process optimization, Scale up study Protocol/Report.
ØHandling of e-change control.
ØHandling of deviation.
ØTo perform the Random audit of manufacturing facility for the compliance of GMP and pre audit preparation.
ØIssuance of BPR’s & ECR’s, Analytical protocol for the testing of Raw Materials, Intermediates and API’s.
ØReview of Master Batch processing and equipment cleaning records.
ØTo perform the sampling of APIs.
ØTo provide line clearances at the time of product change over cleaning.
ØResponsible for maintaining the facility as per approved procedures and cGMP requirements.
ØTo review and retrieve of executed Batch production and Equipment cleaning record.
ØTo give the query response to regulatory affairs.
ØTo ensure that operating procedures, records, work instructions are maintained up-to-date to reflect current practice and are consistent with company and regulatory bodies’ standards, regulations.
ØPart of a successful GMP and Regulatory audits like, WHO, KFDA, PMDA, TGA, HACCP, ANVISA, USFDA.
ØEffective communication, relationship building & man management skills.
ØInitiate team activities to bring in a harmonious work culture within the unit.
PROFESSIONAL TRAINING PROGRAMMES
ØM.Sc. (Industrial Chemistry) with First division From Integral University, Kursi road Lucknow (U.P) in year 2010.
ØOne Month Industrial Training was done during M.Sc Industrial Chemistry in Agron remedies Pvt ltd, Kashipur, U.K.
ØThree Month Industrial Training was done during M.Sc Industrial Chemistry in IND-SWIFT Laboratories Ltd Dera Bassi, Mohali, Punjab.
ØMS Office (MS Word, Excel).
ØHardworking, Dedication, Punctual, Team Leader quality.
ØFather’s Name : Mr. Ambrish Tyagi
ØDate of Birth : 15 Aug 1984
ØMarital Status : Married
ØNationality : Indian
ØLanguages : English, Hindi.
ØPermanent Address : 4B/235 Budhi Vihar Avas Vikas Colony, Moradabad, U.P.
ØHobbies : Reading books, Newspaper, Yoga, Cooking, Playing cricket.
ØI hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.
Date: Ashish Tyagi