PROFILE

Highly motivated science professional seeking a challenging role in the pharmaceutical industry where my education and experience will add significant value. I have proven track record as a validation and quality specialist in sterile injectable non sterile formulations with in-depth understanding on their inherent complexities, and expert in implementation/ remediation of Quality Systems, to comply with CGMPs and achieve organization goals, with balanced approach. I have sound knowledge on global pharmaceutical regulations, and also have significant experience, in working for various regulated markets and globally reputed organizations. Apart from the technical capabilities, an effective contributor to the organization in overall team development. I am looking to take up a challenging role in an organization, which has interests in global arena and seeking significant value addition through quality & compliance.

CAREER HISTORY- 7+years’ experience

DCU Ireland Oct-2016- Present

Research Assistant

I am working as a Ph.D. research assistant responsible for developing and designing of new molecules in neurobiology. Assisting centre director and quality lead for the scale up manufacturing facility. As a part of my duties i have done Staining, Western blotting Protein assays Batch manufacturing in bioreactors and shaker flasks. Environmental monitoring of the GMP facility

Pfizer-India Apr-2015 – Oct-2016

Assistant manager-Quality Assurance (Validation &Engineering)

Reporting to the AVP-Quality, I am responsible for ensuring the quality operations of engineering and validations. Responsible for assuring the quality related to validations and engineering. Implementing and key member in all new projects. Implementation of an effective & robust quality system frame work in pharmaceutical organization, by integrating all the technical operations, in line with global regulatory expectations and at par with Europe/ US based industry standards.

I am key member in sterility assurance (Autoclave,Tunnel &SIP)Review and approval of all types of validation plans (Equipment’s & Software) qualification protocols coming across all the stages (URS, DQ, IQ, OQ, PQ&RQ).Ensuring calibrations and preventive maintenance of the facility in up to date sate.

I was part of managing various internal & external inspections (by EU, USFDA, MHRA-UK, TGA, Health Canada and CDSCO) and enhanced my understanding of the regulatory requirements and standards. Initiating, reviewing and approving of investigations & CAPA plans for the items triggered as a part of internal & external audits.

Dr.Reddy’s Laboratories -India Jul-2013 till Apr-2015

Assistant Manager – Technology Transfer Group

I worked in TTG –Department Central division as Assistant Manager providing technical support to all formulation plants(Orals,Injectables &Semisolids) of Dr.Reddy’s’ Laboratories to streamline the process, to provide validation master plans to perform the qualifications of the equipment, to initiate the new facility qualifications, to perform process validations & media fills for the Injectable divisions and site transfers of the formulations plants and to provide the Cleaning validations approaches,Developing matrices Worst case products cleaning validations. Regulatory support and gap assements wrt to regulatory guidelines.

Preparation and review of technical reports, risk assessments and CAPA plans for the process and equipment’s. Qualifications of Equipment’s & clean utilities like HVAC systems, Compressed air, water system and Nitrogen.

Aurobindo Pharma Limited -India Dec- 2009 to Jul- 2013

Executive – QA

I worked as Executive QA –validations department, successfully completed the new sterile injectable project having 10 manufacturing lines. I was key instrumental in championing GMP certification process of the facility by mentioned regulatory agencies, during my tenure with the organization. I have been instrumental in up bringing the site from commissioning stage to approved stage, through pre-approval inspections. I was responsible to prepare the validation master plans of the facility, Performing Qualifications, Media fills, Cleaning validations and process validations.

My core responsibilities includes preparation / Initiation / Review of URS / DQ / IQ / OQ / PQ / RQ, etc. for all critical equipment’s / utilities / systems. Handling of Change controls, CAPA Management and Investigations. Qualifications of injection filling lines,Blow Fill Seal (BFS) machines, ophthalmic machine & Prefilled syringe machines empowered me to face the success full FDA & EUGMP inspections.

EDUCATION

Master of Pharmacy (M. Pharmacy), in Pharmaceutics, from Tamilnadu Dr.MGR.Medical University, Chennai- India– 2009

Bachelor of Pharmacy (B. Pharmacy), Jawaharlal Nehru Technological University, Hyderabad-2007

SKILLS PROFILE

Team working

Loyalty

Deadline success.

Creativity

Computer skills

Personal details

Language Skills Speak, Write and Read fluently in English, Hindi and Telugu

Computer Skills MS-Office, MS-Project and ERP (as an user)

Date of Birth 11th Feb 1986

Marital Status Unmarried

Nationality Indian

Visa status Ireland-Stamp 2 valid till Oct-2017

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