Regulatory Affair specialist and QA/QC specialist

Geeta Dave

**************@*****.*** https://www.linkedin.com/in/geetadave 857-***-****

CORE COMPETENCIES

FDA and ISO standards,

ICH-GCP, GLP, GMP Guidelines,

NDA, IND, 510(k), IDE, PMA, IVD, HUD, GVP

Clinical, BLA application

QMS, CAPA and Risk management

QA and QC specialist

Pharmaceutical labelling

Design control, Verification and Validation

Visual info soft software for Pharmacy store

Computer Skills –

MS Excel, MS Word,

MS-PowerPoint

SUMMARY

Highly qualified pharmacist with 5 years of pharmacy services along with the QC and QA trained specialist bringing management, administrative and medical experience to retail and institutional settings. Pharmaceutical expertise with relevant qualifications plus experience in analytical method validation, stability studies, analytical investigation with trouble shooting, method transfer and analytical training. EDUCATION

Northeastern University Boston, MA

Master of Science in Regulatory Affairs- Exp Apr- 2019 Drugs, Biologics and Medical Devices (GPA 3.83/4)

Relevant Course Work: New Drug Development, Biologics Development, Medical Device Development, Human Experimentation,Strategic planning management,Food Drug and Medical Device Law and European Union Compliance

Smt.B.N.B. Swaminarayan pharmacy college Gujarat, India Bachelor of Pharmacy Aug-2007 to May-2011

PROFESSIONAL EXPERIENCE

Apanimax PVT. LTD. Ahmedabad, India

QC/QA-Specialist Jun-2011 to Dec-2011

QC/QA control

• Performed tests on outgoing Quality Control procedures and inspected all units.

• Performed titration and chromatography (TLC, HPLC, and GC).

• Conducted routine and non-routine analysis of raw materials, in progress and finished formulations & special projects on analytical problems on a strict timeline.

• Managed CAPA implementation due to outcomes from inspections

• Assisted with investigations and root cause analysis

• Performed a variety of Quality Assurance Operations including developing QC documents, QC audits, QC policies, and Standard Operation Procedures.

• Administered external and internal units and ensured compliance to all quality control protocol specifications.

• Prepared QCP check list and maintained records of Batch Records.

• Developed and followed all written procedures and ensured compliance to specifications.

• Evaluated product production assembly and ensured accuracy in quality assurance records.

• Monitored records of all laboratory tests and investigations. Siddheshwar Medical & Cosmetics Bardoli, India

Retail Pharmacist Jan-2012 to Aug-2016

Pharmacy Technician:

• Entered new patient profiles and prescriptions into medication input software system.

• Accurately recorded compounded products and prepared appropriate labels.

• Maintained drug inventory levels by ordering necessary medications and supplies and verifying deliveries against purchase orders.

• Verified patient data and billing information.

Shiv Jyoti multispecialty Hospital Bardoli, India

Hospital Pharmacist Sep-2016 to May-2017

Pharmacy In charge:

• Dispensed and delivered patient medications to patients throughout the hospital.

• Write guidelines for drug use within the hospital and implement hospital regulations

• Labeled all products appropriately, including cautionary and auxiliary labels.

• Prepare and quality-check sterile medications, for example, intravenous medications

• Regularly completed paperwork and entered prescription and insurance billing information into patient profiles.

• Provided friendly customer service at prescription drop-off and pick-up counters. Strictly maintained customer and patient confidentiality.

• Communicated directly with doctors' offices via telephone, fax and email. ACADEMIC PROJECTS

College of Professional Studies, Northeastern University Boston,

• Prepared Regulatory pathway of Augment Bone Graft System (510 (k)), Teosyal and Fibrin (BLA application)

• Prepared Regulatory Development Plan of Rucaparib and nonclinical pharmacology and toxicology studies of Rucaparib,

• Worked on Advisory committee review, the risk management plan and approval strategy of Lemtrada drug

• Prepared Pre-IND Meeting Request Letter and Pediatric Deferral Equity Act waiver and deferral request letter

• Determined Reclassification of the Knee Joint Patello -femorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis and the Knee Joint Femorotibial (Uni-compartmental) Metal/Polymer Porous-Coated Uncemented Prosthesis.

• Presented pre-clinical plan for use of B-cell therapy in treatment of cancer and autoimmune disease.

• Prepared clinical plan and criticize Regulatory pathway for the B-cell therapy e.g. Tbregs in the cancer treatment.

• Prepared Informed Concerned Form for Safety and Effectiveness study of Donepezil HCL on Alzheimer’s Disease

• Presented Global Regulatory Strategy for Royal Flush Catheter ( UK, Canada, Mexico and Germany)

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