Quality Control Medical

Iqbal Singh Sodhi

****, ********* *****, ***** *****, CA 95051 +1-510-***-**** **********@*****.***

Summary

A highly dedicated and motivated individual with skills in quality assurance and quality control for medical devices and biopharmaceuticals with current and thorough knowledge of FDA regulations, ISO standards and Good Manufacturing Practices

Skills and Abilities

●Assisted in conducting internal audits to perform gap analysis

●Worked on investigating and maintaining CAPA’s

●Maintained and updated electronic document control system

●Conducted quality control tests of in-process material

●Performed visual inspections of finished product

●Assisted in manufacturing steps like chemical release and electro polishing

●Maintained and updated calibration logs of equipment’s

●Reviewed, revised and updated SOP’s and work instructions

●Worked in a GMP regulated environment for Class III medical device (Drug eluting self-expanding stent)

●Took part in weekly quality management meetings and tracked action items for compliance

●Knowledgeable of GMP regulations, FDA QSR 21CFR §820, ISO 13485:2016 and ISO 14971

●Proficient in Microsoft Office Suite

●Possess good oral and verbal communication skills. A quick learner, highly dedicated and motivated individual

Professional Experience

Vactronix Scientific Inc, Quality Assurance Intern, Fremont, CA April 2017 – July 2017

•Assisted director of QA in conducting internal audits as part of an organizational effort to perform gap analysis between current system and ISO 13485: 2016

•Worked on an ongoing CAPA assignment. Determined root cause analysis, proposed corrective action and checked effectiveness of actions taken

•Contributed towards organizations effort to implement a new electronic document management system

•Migrated several documents to electronic document control system (BSI Entropy) including SOP’S, CAPAS, Calibration logs and ISO Standard references

•Transferred several calibration and maintenance logs of equipment’s onto electronic document control system and maintained these logs with accuracy on weekly basis

•Reviewed, revised and updated SOPs to better adhere to ISO 13485: 2016 and 21 CFR 820

•Conducted quality control tests to check tensile strength (Instron) and Af temperature (DSC) of in-process material

•Performed visual inspections of finished products on microscope and reported non-conformances

•Took part in weekly quality meeting, prepared meeting minutes and tracked action items for compliance

•Took part in Pre-clinical planning for Porcine PK study

•Selected simulated use model/vendor for benchtop testing

Alembic Pharmaceuticals, Medical Representative July 2015 – August 2016

•Ensured 100% compliance of monthly reports for comparison of sales of drug products, and record keeping system for the invoices and inventory supplies

•Maintained and managed inventory of Clinical Supplies and payments to wholesalers and Pharmacies on a regular basis

•Assisted in coordinating four medical conferences held within twelve months for 250 Physicians

•Participated in medical camps at Physicians Clinic for 400 patients in six months to test blood sugar level, check blood pressure and perform Neuropathology test

•Counselled clinic patients to improve the management of Diabetes and Hypertension by implementing appropriate diet and physical exercise based on their health condition

Everest Pharma, Quality Control Intern May 2015 – June 2015

●Verified packaging label in accordance with quality control protocol and ensured 100% compliance and met timelines

●Managed inventory of Pharmaceutical ingredients for manufacturing

●Compounded and packaged medications, including unit doses, topical medications and sterile products

References

Will be furnished upon request

Awards and Honour’s

•Received award for best candidate in the training program held by the company in December 2015

•Received award for best presenter in a contest held by company in October 2015

•Earned incentives for 3 months (April 2016-June 2016) for making constant efforts in marketing new drug products which increased the growth in our company sales

Education

UNIVERSITY OF CALIFORNIA SANTA CRUZ SILICON VALLEY EXTENSION

(JUNE 2017)

Clinical Trials Design and Management Certification

MAHARASHTRA INSTITUTE OF PHARMACY (MAY 2015)

Bachelor of Pharmacy

Related coursework

Good Manufacturing Practices

Regulation of Medical Devices

Quality System Regulations (21 CFR §820)

ISO 13485:2016

Interacting with the FDA

Good Clinical Practices

Clinical Statistics

Clinical trials Site Monitoring

Informed Consent Form, CRF and Source Documents

Drug Development Process

Regulation of Drugs and Biologics

Science of Clinical Trials Design

Contact this candidate