Quality Manager Engineering Consultant

Location:

Ahmedabad, Gujarat, India

Posted:

May 04, 2022

Contact this candidate

Resume:

Name: Shivani Nayan Suthar

Address: E-***, Nand Vihar flat, Nr. M.M.Vohra showroom lane,

dabhoi road, vadodara-390010

Mobile: +91-972*******,886-***-****

E-Mail: ***************@*****.***

LinkedIn Profile: - https://www.linkedin.com/in/shivani-suthar-044040110

CAREER OBJECTIVE

To obtain a challenging position with a career growth in a reputed firm and apply my theoretical knowledge in practice where my skills contribute to efficient growth of the firm as well as society.

CORE COMPETENCIES

Coordinator, Site planner, Training & Development, ISO Quality Management Documents Controller, Vendors Evaluator, Leaders, Technical Supporter.

PROFESSIONAL EXPERIENCE

Company: - M/s, Schott Kaisha Pvt. Ltd., Gujarat, India Since 12’2020- Present

Website: www.schott-kaisha.com

Company Profile: The company was established in 1997 as a premium manufacturer of pharmaceutical containers made of neutral glass in India under the name KAISHA Manufacturers Pvt Ltd. In 2008, it started a cooperation with SCHOTT, an international technology group and one of the worldwide leading manufacturers of pharmaceutical packaging with headquarters in Mainz, Germany.

Today, SCHOTT KAISHA is a leading supplier for pharmaceutical industry offering a “one stop shop” solution for the entire range of small volume tubular glass parenteral packaging including ampoules, vials, cartridges and sterile prefillable syringes.

Designation: Sr. Executive- Quality Assurance

Job duties (to be attested from employer)

Preparing and review of standard operating procedure related to testing, inspection and validation.

To perform dimensional inspection of product during production and prepared inspection report for the same and also review it.

Perform visual inspection during production also maintain records.

Maintain inspection report during third party inspection.

To initiate NC reports when required.

Preparing of Calibration,inspection and Validation schedule.

To complete the calibration and inspection and Validation, Qualification & Challenging in time as per schedule.

Maintain and update the Calibration as well as inspection and Validation status.

Preparing and review report, certificate and all documents related to calibration and inspection and validation.

ASS/VSS Management.

Training of GMP and GDP.

Maintain QMS Documents As per ISO 9001 and NABL 17025:2017 Standards.

Maintain Lab requirements as per quality standards.

Done supplier audits as per their specific standards.

Done internal audits.

Participated in the establishment of quality specification and standards for raw materials, in process and finished products.

Confer with management, customers and other representative in planning, scheduling and coordinating the quality plans in conformance with customer requirements, engineering specifications and production schedules.

Assist in the development of inspection and sampling techniques, quality control plans or process control procedures that will ensure the production of finished products which met quality specifications and standards.

Work assignments carried out to the highest quality level.

Performed various other duties and activities as assigned by GM within the physical constraints of the job.

Assist in the investigation of product defects and failures and recommend modification in products, processes or quality standards where such appear to be warranted.

Supervise and perform inspection and testing of raw materials, processes and finished products.

Visit customers and suppliers, when necessary, to confer on specific quality problems.

Training other Inspectors on processes as and when required.

Advanced knowledge of inspection processes and API Q1 Standards..

Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume and ability to read common measuring devices; tapes, micrometers, calipers, etc.

knowledge of metal fabricating and machining technique.

Knowledge about CAPA, root cause analysis, customer complaint.

Maintain 5S systems for smooth operations in department.

Handle team of people.

Monitoring performance of laboratory staffs

Monitoring trainings needs of people for improving performance of quality.

Knowledge about international standards as well as national, American, European standards.

Coordinating with outsourced agencies like calibration, laboratory services etc. regarding technical agreements and qualification protocols.

To do the audit and approve of the external provider.

Prepare the validation protocols for the equipment’s and ensure the status of validation and calibration.

GMP and GDP audit all over the plant and internal audit as per the chedule.

Review and Maintain record of challenging test on daily basis.

Timely uploading of ASS/VSS in IBM notes.

AMC of quality equipment's.

Destruction of obsolete documents.

Company: - M/s, Trivedi & Associates Tecknical Services Pvt. Ltd., Gujarat, India

Website:www.trivediassociates.co.in Since 02’2020-12’2020

Company Profile: Established in 1985, we, Trivedi & Associates Tecknical Services Pvt. Ltd. specializes in offering Engineering consultant, engineering services provider, electric sr. contractor etc. We are serving our clients from Vadodara, India.

Designation: NABL Executive

Job duties (to be attested from employer)

Preparation of Quality Manual /Documents as per ISO/ IEC 17025:2017: - General requirement for competence of testing & calibration laboratory.

Preparation of Laboratory's standard operating procedure and Data sheet for Instruments.

Conduct and follow up the internal audits within the organization.

Attended Internal Audit & Clearing the Non-Conformities received during audit.

External audit ISO/IEC 17025:2017 from NABL assessor and facilitate the audit.

Preparation of Calibration plan and distribute it.

Preparation of internal training record for year and distribute it

Calibration of Measuring instruments like Digital multimeter, Digital clamp meter, Source /Measure calibrators, Transmitter, etc.

Uncertainty calculation of all measuring instruments.

Preparation of calibration certificate.

Responsibility for Preparation of Quotation against tender/ inquiry Received from the customers.

I have Knowledge and worked in pressure and Thermal Departments.

Calibration of measuring instruments like temperature sensor (RTD, T/C), temperature gauge, temperature bath, pressure gauge.

Preparation of purchase/service order as per requirement in ERP system as well as preparation of GRN and SRN receipt.

Planning of technician and engineer for execute site activities.

Company: -M/s, Sensewell Calibration Services. Gujarat, India Since 04’2016-01’2020

Website: www.sensewellcalibration.com

Company Profile: Sensewell Calibration Services over these years have made innovative technical advancements, expertise in providing service & support for business & industries.

All our calibration engineers are well aware of the accreditation values, procedures, formats, work

instructions, uncertainty calculations to perform calibration both in house as well as on site

locations.

We are doing calibration for test equipment’s, process instruments and standards with our calibrated standards.

Designation: Senior Executive

Job duties (to be attested from employer)

Execute master instruments calibration as per prepared calibration plan.

Calibrate different Electro-technical, Thermal & Mechanical (Pressure & Vacuum Gauges) Instruments.

Generate the Calibration Reports along with their uncertainty calculation as per standards of NABL.

Report to Quality Manager if required.

Update the scope of Laboratory as per NABL standards.

R & D on new Instruments for calibration.

Maintain documents like Standard Operational Procedure, Management System Manual, Management System Procedure, Files & Formats as per standard ISO/ IEC 17025:2017 etc.

Prepared quotation as per customer inquiry and renders.

Prepared internal and external training documents as per Guideline of NABL.

Execute internal and external audit as per their frequency.

Prepared circulars of audit activities.

Planning of engineers for site calibration.

Company: - M/s, Systems Engineers, Gujarat, India. Since 07’2014-03’2016

Website: www.gii.co.in

Company Profile: Gujarat Instrumentation Institute (GII) was established in 1996 as a proprietary concern and placed at GII started with Maintenance, Calibration. Over the period of time "GII" has acquired expertise and knowledge in the field of Calibration of process control

Instruments, Electrotechnical, pressure and Thermal Measurements. GII provide Calibration services at GII's Laboratory. The Yenkay Calibration services have enabled customers to improve their product quality.

Designation: Calibration Engineer

Job duties (to be attested from employer)

Calibration of Measuring instruments like Digital multimeter, Digital clamp meter, Source /Measure calibrators, Transmitter, etc.

Calibration of thermal instruments which is using all pharmaceuticals company.

Prepared report as per customer requirements for all instruments.

Coordinate with customer for query about instruments error and other things.

Assemble temperature bath as per wiring diagram.

Do R&D of temperature bath after assemble process.

Prepared Standard operating procedure of each instruments and calibration method.

Check calibration status about master instruments and send it for calibration every year.

Prepared stickers of instruments for validity of instruments.

ACADEMIC QUALIFICATIONS

Bachelors’ in Electronics and Communication from Sardar Vallabhbhai institute of Technology, Vasad, Gujarat Technological University, India in Aug’2011-May’2014.

Certifications/ Diplomas or Work-related trainings.

Diplomas’ in Electronics and Communication from Parul Polytechnic institute, Waghodia, Limda, Gujarat Technological University, India in July’2008-June’2011.

Done training in operation of Electrical, pressure, mechanical parameter from Fluke, USA, Vadodara, in April 2016.

Done training in NABL IEC/ISO 17025: 2005 from Devanshi Consultancy Services in May'2016 and Jan'2018.

Done training in NABL IEC/ISO 17025: 2017 from Devanshi Consultancy Services in July'2018 and Aug’2018.

Done training in ISO 9001:2015, Vial ISO 8362 Part 1 and Part 2, Ampoule ISO 9187 Part 1 and Part 2 in Jan’2021.

Done Autocad software.

Done training in SAP, ERP, Microsoft office.

Reference

Mr. Vivek Panchal

Calibration Executive

Schott Kaisha Pvt. Ltd.

+91-799*******

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