Quality Assurance Manager

Hashim Vakkayil

Television Street, Al Mahjr, Jeddah, Kingdom of Saudi Arabia

**************@*****.***/ Tel Mob: +966*********

CAREER OBJECTIVE

To obtain a challenging position in an admired life science or pharmaceutical organization, where my talent and skills will be put towards successful achievement inclined to professional growth enhancing reputation of the organization.

PROFESSIONAL EXPERIENCE

Pharmaceutical Solutions Industry, Jeddah, Kingdom of Saudi Arabia.

Quality Assurance Officer, September 2014 - Present

Responsible for maintaining all quality aspects of product manufacturing and helping to enforce quality assurance policies and good manufacturing practice covering the safety, design, production and inspection.

Some of the major responsibilities include:

Responsible for monitoring and maintaining quality and compliance targets.

Monitoring and auditing of products and records to ensure high standards of quality.

Ensuring the product meets product specifications.

Performing line clearance prior to start up of production activities.

Ensuring products comply with the good manufacturing practice.

Provide weekly and monthly reports to senior managers.

Keeping quality documentation up to date.

Identify training needs among the staffs and recommendations to improve product quality.

Responsible for the review and update of the programme quality plans.

Handling release of finished products on SAP.

Preparing annual product quality review.

Updating and reviewing standard operating procedures.

Managing CAPA and Non conformance and reviewing closure details.

BIONEST Biotechnology incubation center, Cochin, India.

Quality Assurance Inspector, February 2014 August 2014

Worked as quality assurance inspector for BIONEST Biotechnology incubation center at the KINFRA Biotechnology Hub, Cochin, India. Different duties with deadline were assigned individually under severe scrutiny of senior scientists. Some of the several duties performed include:

Worked in scientific team that drafted the layout for different labs and research units at BIONEST. Five main units where set up accordingly.

Monitoring the installation process and regular inspection of different equipment such as PCR machine, Genetic analyzer, LCMS MS, Liquid chromatography, Gas chromatograph, De ionizer, Fermenter etc.

Preparing and reviewing of standard operating procedures (SOP).

Reviewing planned preventive maintenance schedule for different machineries.

Environmental monitoring and routine inspection of clean rooms.

Rajiv Gandhi Center for Biotechnology, Thiruvananthapuram, India.

Research Assistant Trainee, July 2013 - January 2014

Worked as research trainee in laboratory medicine and molecular diagnostics unit at Rajiv Gandhi Centre for Biotechnology. Duties performed include:

Handling infective biological samples such as whole blood, serum, plasma, body fluids, conjunctival swabs and throat swabs under aseptic conditions for processing and detection of genetic aberrations.

Sample collection, classification and separation of human/viral DNA/RNA.

ACADEMIC PROFILE

Master of Science in Biotechnology (2012)

Northumbria University, Newcastle upon Tyne, United Kingdom Graduated with Commendation honor.

Bachelor of Science in Biotechnology (2009)

M.S.Ramaiah College of Arts Science and Commerce, Bangalore, India with higher

First class.

10+2 (2006)

I.E.S Public school, Trissur, India- 72%

10th (2004)

N.E.M.S school, Karuvarakundu, India- 80%

RESEARCH EXPERIENCE

Project Title: Optimizing bioprocess or scaling up of industrial process using

Recombinant protein

Center : Industrial biotechnology lab, Ellison Building, Northumbria University

Project Title: Expression of Pectate lyase gene in E.coli BL21 (DE3) cells and purification study.

Center : Molecular biology lab, Ellison Building, Northumbria University.

POSTER PRESENTATION

Poster Presented on Breakdown of Bt- Insect resistance towards Bt crops at Northumbria University, Newcastle upon Tyne, UK.

Poster Presented on Rise and demise of Flavr Savr tomatoes at Northumbria University, Newcastle upon Tyne, UK.

Poster Presented on Fermentation technology at M.S.Ramaiah College, Bangalore, India.

FIELDS OF INTEREST

Quality assurance, Quality control, Biotechnology, Genetic Engineering, Immunology, Molecular biology, Bioprocess, Molecular diagnostics, Pharmaceuticals, Research and development.

COMPUTER SKILLS

SAP.

MS Office Word.

MS Office Excel.

MS Office PowerPoint.

MS Office outlook.

PERSONAL INFORMATION

Date of Birth : 21st December 1987

Nationality : Indian

Sex : Male

Marital status : Single

Languages known : English, Malayalam and Hindi.

Hobbies : Photography, Reading

Strengths : Good communication skill and an eminent team player

Permanent address : Bhavanamparambu, Karuvarkundu (P.O), Kerala, India,

676523

REFERENCES

Dr. Bassam M Elmadhoun

Quality unit Manager/Technical training Manager

Pharmaceutical Solutions Industry

Industrial state, Phase 2

Jeddah, P.O Box: 17476

**********@***.***.**

Dr. Radhakrishnan R Nair

Head, Laboratory Medicine and Molecular Diagnostics

Rajiv Gandhi Centre for Biotechnology

Trivandrum

*************@****.***.**

Dr. Rinke Vinkenoog

School of Life Sciences

Northumbria University

Ellison Building

Ellison Place

Newcastle upon Tyne

NE1 8ST

*****.*********@***********.**.**

DECLARATION

I hereby declare that the information stated above are true and correct to best of my knowledge and belief.

Hashim Vakkayil

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