Quality Assurance Customer

CURRICULUM VITAE

(Experience *.* years)

K. ADINARAYANA

Mobile: +91-809*******

E-mail: *************@*****.***

Objective

To pursue my career in a pharmaceutical research organization where one’s innovative ideas, technical skills and abilities can be utilized for the career advancement and to augment growth of organization.

Work Experience

i worked on Design and Development of Surgical Suture Coated with Curcumin Gold nanoparticles” this is granted project in Department of Science & Technology, approved by Government of India. From july2013 to 2014 September.

I worked as Executive in Quality Assurance Department (QA) in BIOCON ltd (USFDA, MHRA, WHO and ISO Approved Company) at Bangalore, India. From December 2014 to August 2016)

Currently im working as Associate in Quality Assurance –Injectables in Mylan Laboratories Limited, India.

From August 2016 to present.

I had certified in QMS Lead Auditor course ISO 9001:2015 in International registered certified auditor (IRCA).

Current Job Responsibility

Execution and compilation of process validation, Cleaning Validation protocols and Reports.

Responsible for in process activities giving line clearance in Dispensing, compounding, Dry Powder filling, Liquid filling sealing, external vial washing area.

Responsible for Area Qualifications (NVPC Monitoring, Air velocity).

Execution for Qualification of vial washing machine, Autoclave and tunnel.

Environmental & Personnel monitoring of grade A, B and C areas

Responsible for Preparation of sampling plan and collection of in process samples during batch manufacturing.

Review of BMR, BPR’s and Medial fill.

Coordinating with Production for validations and routine production plan.

Co-ordination with Stores, Quality Control, Production & Engineering Dept for smooth production activity.

I had faced the Regulatory and Customer Audits: USFDA, EU, TGA and Customer Audits.

Handling of investigation of Deviations, Out of Specification and Out of Trend.

Supported document required for queries Received from US and EU regulatory bodies and customers about the product.

Previous job Responsibility:

Keeping the documentation and manufacturing process of products on par with ICH guidelines.

Preparation and review of Annual Product Quality Reviews.

Preparation and execution of process and cleaning validation & verification protocols and report and providing the same for the regulatory documentation.

Supported document required for queries Received from US and EU regulatory bodies and customers about the product

Assist in customer and regulatory audits and providing documentation support for the same.

Handling of investigation of Deviations, Out of Specification and Out of Trend.

Issue, review and approval of Batch Manufacturing Record and Packing and Dispatch Record.

Monitoring the process of manufacturing, cGMP compliance, sampling activities, packing and dispatch activities. Verification of Finished Product Labels, Preparation and review of SOP’s.

Key contributions:

Coordinated and provide necessary document support during regulatory and customer audits. Efficiently provided required documentation support during USFDA audit, EU Audit and various customer audits.

Prepared process validation and cleaning verification protocol and report for regulatory submissions.

Performed effective cGMP - IPQA activities and co - ordinated during customer and regulatory audits, assisted in handling of investigation of OOS, OOT and deviations.

Prepared annual product reviews inline and on time.

Technical and personal skills

Good communication skills

Effective command over verbal and written communication with good interpersonal skills

Hard-working and confident & Good in computer applications (M.S. Office)

Problem solving attitude and Team work

Flexible and ability to work effectively under stressful environment.

Strong knowledge in Quality ICH guidelines

Updated knowledge in regulations of authorities handling.

Good documentation practices and good manufacturing practices.

Instruments handled UV/VIS spectrophotometer, HPLC, probe sonicator, Compression machine, Zeta sizer, Brook field viscometer.

Preformulation Studies such as solubility studies, drug-excipients interaction studies, and solid-state characterization of drugs etc. using physical techniques like DSC, FTIR, and PXRD.

Stability studies designing and execution

Experience in Development of polymeric sustained release micro particulate drug delivery systems, nanoparticles, transdermal patches suspension, syrups, tablets, capsules, and other conventional dosage forms.

Educational Qualifications

Qualification

Name of the institute

Year

Aggregate percentage

M.S.(pharma) in Pharmaceutics

National Institute Of Pharmaceutical Education And Research (NIPER),Hyderabad

2012-14

7.20CGPA

Bachelor in Pharmacy (B.Pharm)

Ragavendhra institute of pharmaceutical education and research (RIPER),Anantapur

2008-12

68%

Higher Secondary

A.P.Residential Jr. College, kodigenahalli, Anantapur

2005-07

87%

S.S.C.(X)

Z.P.HIGH School, sevamandir,Anantapur

2004-05

80%

ACHIEVEMENTS

Qualified NIPER-JEE 2012Exam

Qualified GPAT 2012 Exam

Successfully completed course “General Course on Intellectual Property” WIPO in 2013.

ACADEMIC PROJCET

“M.S Pharma Project “Design and Development of Surgical Suture Coated with Curcumin Gold nanoparticles” which is granted project in Department of Science & Technology, approved by Government of India under the guidance of Dr. Sunitha, NIPER, Hyderabad.

Symposium/workshop attended

Completed course work in Drug Discovery- Conceptualization to Commercialization & IPR (D2@C2) -2012 workshop jointly organized by Novartis and NIPER Hyderabad.

I have actively participated in BIO ASIA 2013, ‘The Global Bio Business Forum’ held at HICC genome valley Hyderabad.

EXTRA CURRICULAR ACTIVITIES

Participated in ‘National Cadet Corps (NCC) camp’ 2004.with “A” certificate.

Participated in National Service Scheme (NSS) camp.

Participated in District Secondary School Athletic Association 2002-2003.with volley ball certificate.

Participated in Eenadu Cricket League – 2012.

Personal Details

Fathers Name

: K.Mallaiah

Mothers Name

: K.Adilakshmamma

Gender

: Male

Date of Birth

: 8th feb, 1990

Nationality

: Indian

Religion

: Hindu

Permanent Address

: H.no 5-1-197,

Sreekantapuram (vill&post),

Hindupur (Mandal)

AnantapurDist,

Andhra Pradesh.

PIN: 515201,

Ph. +91-809*******

Languages Known

: English, Telugu and Hindi

Hobbies

: Reading journals and playing cricket

Declaration

I do hereby declare that the information furnished above is true and to the best of my knowledge. In case of my selection to your esteemed organization, I shall dispatch my duties at the earliest possible and to the utmost satisfaction of my seniors.

Place: Bangalore yours faithfully

(K.Adinarayana)

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