A.

NARAYANA
Mobile: +91 -9490189001
+91-9704678553
E-Mail: anugonda_chari@rediffmail.com
anugonda1978@gmail.com

Seeking Senior Level assignments in Quality Assurance with reputed organizations in

Pharmaceutical Industry.

________________________________________________________________CAREER APERCU
A thorough professional with over 16+ years of rich experience in Quality Assurance and Compliance
activities. Presently designated as Manager-QA with Malladi Drugs & Pharmaceuticals Limited, Unit-
5, Tirupati (Malladi Group) and approved chemist by DCA, Govt of AP. In-depth knowledge about
various Quality Standards and proficiency in implementation of the same. Proficient with modern concepts of
value engineering, costing with demonstrated abilities in optimum resource utilisation. Experience of facing the
regulatory audits of US FDA, Written confirmation and WHO GMP. Experience of implementing ISO
9001-2008 systems. Possess knowledge of ICH guidelines for API manufacturing. Ensuring compliance with
quality standards & maintaining all related documents.

_____________________________________________________________PROFICIENCY FORTE
- Planning and Execution - Batch Release - Process Validation and Evaluation

- Internal Audits - Stability Studies - Training and Evaluation

- Inventory Control - Change Control Management - Team Management

- Man Power Planning - Vendor Approval - BPR & BCR Maintenance

- Support to Regulatory Affairs - Document Control - Annual Product Review

- Support to Marketing Department - Handling of OOS - Cleaning validation

- Regulatory and customer audits - Handling of licensing work related to drug licenses

Functional Skills

Planning & Control

Overseeing production related trouble shooting in multipurpose plant and involving in technology transfer.

Participating in failure investigation (out of specification) and conducting causal analysis of the problem
and identifying major root causes and proposing corrective and preventive actions

Reviewing and approval of BPR, MFR, BCR, SOPs , Protocols, Specifications and Test Methods

Resolving customer complaints, implementing cGMP and ensuring its compliance

Handling of Contract manufacturing of Purac Corbion.

Quality Assurance

Conducting continuous audits to ensure cGMP compliance.

Providing feedback to top management based on Quality Audits & rendering suggestions for improvement.

Ensuring that the teams adhere to all the quality standards and procedures through monitoring sessions.

Taking initiatives through various training programs in coordination with training teams to optimise and
take corrective actions on the basis of quality checks.

Preparing SOPs and generating various reports / documents as per ICH guidelines.

Experienced on facing the regulatory audit like US FDA, Written confirmation, GMP and Customer
audits like BSP (Germany), Sanofi, Merck, Johnson matthey, Degussa (Germany), Dupont, P& G etc.,,
Apotex, Teva etc.,

Trainings

Optimum utilization of existing facility and reducing the manufacturing costs by implementation of Value
stream Mapping (VSM) and SEDAC

Up-keeping facility in cleaning implementation of 5 S concepts.

Team Management

Imparting training on manufacturing process and safety measures.

Creating an environment that sustains & encourages high performance.

Motivating teams in optimising their contribution levels and training the people in cGMP.

_____________________________________________________________CAREER HIGHLIGHTS

Apr15- Till date Manager QA with Malladi Drugs & Pharmaceuticals Ltd. Unit-5 Tirupati

Jan2000 to Mar14 Carrer Starts from Trainee, getting the promotions as Jr.Officer. Officer,

Sr.Officer and Asst Manager, working in various areas in production & QA

with Malladi Drugs & Pharmaceuticals Ltd. Unit-5 Tirupati

_________________________________________________________ACADEMIC CREDENTIALS

Bachelor of Science B.SC (MPC) from Sri Venkateswara University,Tirupati

Master of Science (Chemistry), from Kevumpu university, Karnataka

Presently perusing Ph.D (chemistry) in Sri Venkateswara University,Tirupati

_______________________________________________________________PERSONAL DETAILS

Father name : Venkata Charyulu

Date of Birth : 02nd July 1978

Languages : Telugu, English and Tamil

Address : 1-67/1, Vaishnavi Nagar, Pudi Road, Tiruchanur, Tirupati-517503.

Contact No. : 09704678553, 09490189001

Passport No. : H8632348, issued on 22.04.2010, Place of Issue: Hyderabad, Andhra Pradesh,India

______________________________________________________________________Reference

M.Vishweshwer
Sr.Director (Production)
M/sBiocon Ltd.,
Hyderabad
ContactNo.: 09505021906

V.P.Maroo
Contact No.: 9916217863