Quality control manager

B.Anand kumar,

#* -*******,

MADHAVAM HERITAGE

TC 11 369-1,KUTTUMUKKU,

RAMAVARMAPURAM

THRISSUR DT

KERALA,INDIA

Mobile No. +919********

CAREER OBJECTIVE:

To obtain a pivotal position in Pharmaceutical Industry and to grow along with values and business of Organization.

Willing to adapt and learn along with the values and innovations of organization by

self learning and contribution .

EXPERIENCE & DETAILS (17 Years)

Working with Akesiss Pharma as Manager –QC since June 2018 .

Organization Name and Place of the Unit

Duration

Designation

MICROLABS LTD,JIGANI

June2016

June2018

Asst Manager CQA

Adcock Ingram Limited,

Medriech-Meiji Group,

Bangalore

August 2015

June 2016

Executive-I

Microlabs Ltd,

Hosur,Peenya &Jigani Unit,

Bangalore

Nov 2006

July 2015

Sr. Exe QC

Katra Phytochem

pvt ltd,Bangalore

Feb -2006

Oct -2006

Jr. Chemist

Sai Mirra Innopharm

Pvt Ltd, Chennai

Oct. 2003

Feb 2006

Trainee to Chemist

Software Handled:

Empower 3, Chemstation, Class-VP, LC Solution, Labsolution 5.61(DB Version) LIMS-Caliber 5, i-Hitz MS, Progen ERP,IR Solutions.

Instruments Handled:

Ultra Violet Visible Spectrophotometer (UV-1601Shimadzu)

Infra Red Spectrophotometer (FTIR –8400 Shimadzu,IR Affinity)

HPLC, Auto Injector Shimadzu (LC 2010 AHT,CHT,2030 i series),

Prominence 10A &20A,Voglibose Applications with Fluoroscence detector.

HPLC, Auto Injector (Agilent 1100 &1200)

HPLC, Auto Injector (Waters 2489)

Dissolution Apparatus (Electro lab USP Type XX III),LabIndia DS800+,

LabIndia DS 8000

Certifications:

Competent Technical staff, Drug control, Karnataka -2013

( Approved By Karnataka Drug control)

Competent Technical staff, Drug control, Kerala -2018

( Approved By Kerala Drug control)

JOB PROFILE IN Akesiss Pharma – Kerala (June 2018 onwards to Present ):

Responsible for all Quality control activities

Releases of RM, PM, Planning and execution, timely releases,coordination with cross functional departments for smooth functioning of organization .

Method verification of newly launched products

Responsible for controlled and planned inventory of lab items considering regulatory and organization requirements

Training of chemists for cGLP.

Handling a team of 10+ professionals.

Hierarchy: Reporting to Plant Head, Exe Director

JOB PROFILE IN MICRO LABS LIMITED – JIGANI (June 2016 –June 2018):

Responsible for Evaluation of new formulations from party, critical samples, Pharma compliance samples,planning, Interacting with client regarding clarifications and queries regarding analytical issues.

Responsible for Joint analysis at third party manufacturing sites, QC visits document verification related to new products and QC aspects.

Coordinating with regular QC for new products analaytical issues if any.

Responsible for planning QC activities for new product launch based on priority coordinating with SCM and CQA as and when required.

Review of analytical reports,Stability data’s provided by client,method compatibility verification,regular follow ups for analytical requirements with client.

Providing inputs for pharmacopeia draft preparations,updations,supporting CQA technically.

Hierarchy: Reporting to VP-QA/AVP QC

JOB PROFILE IN ADCOCK INGRAM LIMITED – -MHRA /TGA/MCC BANGALORE (Aug 2015 – June 2016):

Good Knowledge on CGMP,GLP and maintaining records

Instrumental Analysis and review of report through LIMS

Results Transfer through CDS from Empower.

Incident reporting,Root cause and CAPA.

Co-ordinating with Senior/,Junior level for Analytical planning.

Hierarchy: Reporting to SM/GM QC

JOB PROFILE IN MICRO LABS LIMITED – HOSUR / PEENYA/JIGANI (Nov 2006 –July 2015):

Routine follow up of requirements for timely output and releases.

Training of Chemists .

Analysis for assays, impurity profiles, dissolution.

Good Knowledge of trouble shooting in HPLC.

Calibration of instruments, UV-Spectrophotometer, HPLC, Dissolution apparatus

Analysis of various Inprocess,finished samples such as Injections Tablets,capsules,Ointments,,Liquid preparations

Performing the Dissolution Profiles for Immediate release and Delayed release tablets,capsules.

Performing column performance based on performance certificates.

Preparation of tentative analytical records .

Preparation of SOP’s.

Performing Joint Analysis at Third party manufacturing sites and co-ordinating with manufacturing QC during new product launches .

Assisting Indent of HPLC Column,Accessories, and Spares based on requirement.

Preparation of periodic Calibration schedules,PM AM and planning.

Assisting Internal Audits.

Daily and weekly report preparation, ensuring that current and updated specifications, testing procedures and standard operating procedures are available in the laboratory.

Responsible for evaluation of Generic products as per client methods, Inhouse and pharmacopeial methods

Report review,preparation of COA.

Hierarchy: Reporting to AM/GM QC

.

JOB PROFILE AT SAI MIRRAINNOPHARM PVT LIMITED, CHENNAI (Oct.2003 to Feb.2006):

Undergone Training in QA activities and worked under the guidance of DRL/Amway Representatives in Sai Mirra Innopharm Pvt Ltd .

Analysis of Inprocess samples,finished products .

Inprocess checking and line clearance activities,such as Physical parameters setting at compression,filling and coating stages,Stereo Approval, Foil approval at initial stage of packing,Online cross checks during compression coating and packing,and random checks to ensure that the standards are followed and Quality is maintained throughout the process without any deviation.

Calibration of instruments UV-Spectrophotometer, Dissolution apparatus

Process validation sampling,Inprocess sampling and Finished product sampling

Assisting in preparation of Annual Product Quality Reviews.

Performing swab tests and approving the area for dispensing,manufacturing and packing and QA activities in shift basis.

Issuing Batch Manufacturing and Packing Records,Data sheets to Production and QC.

Hierarchy: Reporting to DM/AM- QA/QC

EDUCATION:

Bachelor of Bachelor of Chemistry (B.Sc Chemistry)

Calicut University,Kerala, 2000 – 2003

M.Sc. Chemistry 2009-2010

(Vinayaga Mission University, Salem)

Computer Skills

MS Office

PERSONAL DETAILS:

Date of Birth : Dec 14, 1982

Gender : Male

Marital Status : Married

Passport Number : P3525908

Pan card No : BCUPK 6034P

Nationality : India

Permanent Address:,

#6 -LAKSHMI,

MADHAVAM HERITAGE

TC 11 369-1

KUTTUMUKKU,

RAMAVARMAPURAM

THRISSUR DT

KERALA,INDIA

PIN: 680631

References :

1 .G Mallika QA Manager,Saimirra Innopharm Pvt Ltd,Chennai

2 .GVS Rao AVP QC, Microlabs Limited,Bangalore

3.M S Manjuath VP QA, Microlabs Limited,Corp. Office,Bangalore

4.U S Deekshit Manager CQA,MicrolabsLimited, Corp. Office,Bangalore

5. P Kumaresan QC Manager, Adcock Ingram Pvt Ltd

6. MK Nair Exe Director, Akesiss Pharma,Cochin,Kerala

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