Quality Assurance Medical Device

**** ********* ****, *** #**** 617-***-****

Shreya Gandhi

Framingham, MA 01702 ***************@*****.***

EXPERIENCE

Quality Assurance Compliance Specialist Genzyme Corporation, USA Nov 2011 - Present

Duties

Review and approve completed batch documentation, production records, assay data, and associate d logs

for intermediate and final release.

Ensure that documentation and operations meet established requirements of cGMP's, internal SOP's and

Organizational policies.

Participate and/or lead team to investigate deviation to determine appropriate root cause and CAPAs and

responsible for CAPA resolution.

Maintain metrics which drive achievement of 95% RFT .

Partner with Manufacturing and MTS to implement systematic solutions which deliver RFT deviations .

Observing Thyrogen purification process firsthand and advising manufacturing department to ensure

continuous compliances with cGMP and regulatory standards during various ongoing processes.

Demonstrated the ability to consistently provide OTF expertise whilst enduring QA shift rotational schedule.

Detail understanding of all manufacturing process including protein purification, buffer preparation, cell

culture, media and equipment prep.

Achievements

Reviewed as the most critical QA compliance agent for release of lot summary for multiple batches to support

the product release team for 2013.

Flexibility to adapt to changing priorities by demonstrating the ability to adjust to an ever changing

manufacturing schedule, issued batch record last minute and come in on and off day to complete lot

summary.

Sense of urgency and completion of deliverables on time by releasing up to 4 intermediates of “Thyrogen” in a

day so that QA Purification group meets its commitment to our external and internal customers.

Proved to Work independently on Night shift for supporting all operations.

Ability to give manufacturing a direction when question is posed during night operations.

Developed relationships among other manufacturing groups which aided in consistently completing Quantic

observations within the 14 day requirement.

Clinical Pharmacist Intern Wockhardt Hospital, Mumbai, India May 2008-Jun 2008

Performed audits, patient counseling, ward rounds, adverse drug events reporting, case studies, health

care workshops, dispensing, and group discussions with doctors from different departments.

EDUCATION

GPA-3.6/4.0

Master of Science in Regulatory Affairs of Drugs, Biologics and Medical Devices

Jan 2010 –Aug 2011

Northeastern University, Boston, MA

Relevant Coursework: US FDA regulations for Drugs, Medical Devices, and Biologics, New Drug Development,

Biotech Product Registration, European Union Compliance Process, ISO 13485 and 9001, Quality System

Management, 510(k), PMA, Product Recall, Medical Device Reporting, GLP, Human Experimentation and Clinical

Laboratory Management,, Patent Exclusivity, and FD&C Act.

Projects:

IND Submission: Prepared a mock IND submission as a team, primarily focusing on chemistry,

manufacturing and controls of a drug product.

Internal Audit Checklist: Formulated Internal Audit Checklist and identified quality documents

pertaining to Process Qualification and Validation referencing to 21 CFR 820 and ISO 13485 to reduce

risk

Risk Management: Implemented an effective CAPA, monitored the data, and designed FMEA activity

for the medical device product.

505b (2) Application process: Prepared a briefing package explaining the 505b (2) process

specifically in terms of its submission content.

Regulatory procedures (European Directives): Classified the device, selected conformity route,

notified body, and prepared essential requirement checklist and declaration of conformity to obtain CE

mark.

Response to Warning Letter: Identified non-compliance in FDA warning letter. Suggested the

Corrective and Preventive Action (CAPA) according to 21 CFR Regulations.

FDA Mock Meeting: As an FDA member reviewed the stability profile of biological drug to support the

clinical program submitted by sponsor for the approval in the market.

Regulatory Research of India: Researched the registration and regulatory requirements for marketing

a Biotech Product in India. Analyzed preclinical, clinical trials, regulatory authorities review, post

marketing and safety surveillance for a selected product

Bachelor of Pharmacy May2005-Jun2009

University of Mumbai, India

Relevant Coursework: Pharmaceutics-Quality Control and Quality Assurance, Biotechnology, Pharmaceutical

Chemistry,Pharmacology,Pharmacognosy,Pharmaceutical Analysis, Anatomical and Physiological Process

and General Biochemistry.

SKILLS AND EXPERTISE

Production Record review GMP, FDA,EMA Regulations

Regulatory Submissions Deviation/ Investigation, CAPA

Product Disposition Knowledge of 21 CFR

LIMS, Track Wise Clinical Trails and Knowledge of ICH

Guidelines.

Medical Devices

INTERESTS

Playing badminton, Swimming, Trekking, Exploring new places, listening to the Music.

Reference will be furnished upon request

Contact this candidate