Quality Function

CURRICULUM VITAE

MANIKANDAN K

A** /*** China cluster, International city, Dubai.

Mobile: +971-********* Email: *********@*****.***

QUALITY PROFESSIONAL

Strong credentials in instrumentation analysis, implementing quality systems and lab management

PROFILE

Competent and committed quality function 9+ years professional career success in conducting instrument analysis and implementation of quality function systems & procedures with pharmaceutical industry.

Demonstrated capabilities in performing analysis of samples and preparing structured analytical reports highlighting variations.

Professional strengths in handling, calibration and maintenance of sophisticated lab instruments.

Fine-tuned analytical and problem solving skills with abundant positive attitude.

Superior written and verbal communication.

Key strength areas include:

à Instrument Analysis à Quality Control à Lab Operations/ Procurement à Instruments Calibration à Problem Resolution à Analytical Reportingà Team Management à Cross Functional Coordination

PROFESSIONAL EXPERIENCE

HOLISTIC INTERNATIONAL TESTING SERVICES FZ-LLC., Dubai. Since May 2015 working as a senior chemist.

SGS INDIA PVT LTD., Chennai, India. From Oct 2010 to May 2015 Worked as a Quality control- Executive

Client service for ASTRA ZENECA INDIA LTD., Bangalore since Nov 2012 –Nov 2014

ORCHID CHEMICALS AND PHARMACEUTICALS LTD, Chennai, India. since Mar’2006-2010 SEP

A globally recognized, integrated pharmaceutical company with core competencies

Job Profile:

Analysis of metabolite products and Food supplements by LCMS Instrument.

Method development of Aflatoxin in Metabolite and Hormone compound by LCMS.

Method validation and verification activity in LCMS Analysis and HPLC

Method validation of water soluble vitamines in Energy drink By LCMS

Method development of Chlorhexidine and Triclosn in oral products by HPLC.

Analysis of assay, chromatography purity and related substance in HPLC for Finished product, API and Raw material.

Method development of p-Phenylene diamine,4-Aminophenol

Preparation of standard solution and volumetric solution as per Pharmacopeia

Method transfer analysis of Finished product and API products

Initiation of method validation for formulations as per ICH guidelines and Pharmacopeia requirements.

Analysis like Assay, Related substances and Dissolution for the new projects.

Preparation of standard operating procedures (SOP), standard testing procedures (STP), certificate of analysis (COA) for drug products.

Analysis of Finished drug products as per the stability protocol and stability conditions.

Transfer of validated method from ARD to QC lab by method transfer.

Experience of handling ANDA projects for US and UK market as per the regulatory requirement.

Analysis of wet parameters and Calibration of HPLC,UV,Dissolution and IR

Assessments of PQ for the instruments comply with CGMP and lead to 5S activities in the lab.

Projects Handled:

US, UK/EU, DAC and Indian markets.

Formulations like solid dosage, liquid orals, sterile preparations –injectables, semisolids etc.,

Handled the project of Cephalosporin API project for submission to USFDA,WHO

Products, Tuberculosis and Oncology drugs and handled the Narcotic drugs

Instruments Skills:

LCMS, HPLC, Dissolution.

UV-Spectrophotometer, FT-IR, Polari meter and KF-Titrator.

Timeline Skills:

Knowledge of ICH guidelines, stability indicating methods and regulatory requirement for filing of stability data in US and UK market.

Internal audit strategies and shaping the team members to face regulatory audits.

Acquisition of timeline assessment with senior officials of different departments for the pipeline of the projects to be structured.

Management and leadership achievement of handling a team for analytical department.

Coordinating with the QA/QC personnel and identifying the quality failures and initiating the system and process changes for qualitative improvement.

Management of timelines, quality and preparation of statistical data and to ensure that they comply with the projects and regulatory guidelines.

EDUCATIONAL & PROFESSIONAL CREDENTIALS

M.SC Chemistry – 2006-2008

Distance Education in Madurai Kamarajar University, Chennai, India

B.SC Chemistry – 2001-2004

Arulmigu Palani Andavar Science and Arts, College Affiliated to Madurai Kamarajar University., Palani, India.

COMPUTER SKILLS: MS Office

Date of Birth: 3rd April’1984; Passport No: G7556237; Martial: Married; References: Available on request.

APPLICANT’S NAME

K.MANIKANDAN.

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