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Quality Assurance/ Pharmacovigilance/ Drug safety / Compliance

Location:
Edison, New Jersey, United States
Posted:
September 11, 2018

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Resume:

SUMMARY

Experienced Quality Assurance Professional with demonstrated history of working in retail pharmacy and pharmaceutical industry. Professional skills in product complaint investigations, CAPAs, Data Analysis, ADE Reporting, Medical Case Assessment/Review, Quality Auditing and Pharmacy Practice. Able to multitask and manage ongoing priorities both independently and in a team environment with exceptional organizational, problem solving, time management and strategic skills.

EXPERIENCE

Compliance Specialist 07/2017 - Present

Lupin Pharmaceuticals, Inc.

Training staff on product complaints as a subject matter expert.

Participating in the development of the compliance training curriculum and course management.

Triaging ADEs/ PQCs and MI and forwarding to respective department.

Preparing corporate quality monthly and quarterly metrics pertaining to product complaints.

Reviewing and reporting metrics across the organization in order to identify emerging trends or potential risks.

Drafting and disseminating written policies and standard operating procedures related to compliance activities.

Supporting GxP client audits and regulatory agency inspections.

Supporting Quality Agreement preparation and assisting with Field Alert Report (FAR)/Product Recall filing.

Complaint Coordinator 07/2016 – 07/2017

Lupin Pharmaceuticals, Inc.

Maintained customer product complaint database (QAMS) and departmental product complaint quality metrics.

Conducted product complaint investigations (paper based/electronic) to determine root cause using 5WHYs technique, when necessary, followed by implementation of corrective and preventive actions (CAPA) to improve product quality.

Handled complaint intake, classification, severity assessment and closing letter follow up activities.

Issued management notifications for critical product complaints to assist with timely Field-Alert Reporting (FAR).

Provided PQC/DPC data for metrics, APRs, and Quality review forums followed by supporting management review board meetings.

Provided support to all GMP QAMS Modules including Change control, Deviation and CAPA.

Provided recommendations for continuous improvement of product complaint to meet industry standards and regulatory guidance.

Facilitated sample return with Designated POC/ Logistics for return product assessments.

Performed routine reconciliations of product quality complaints with drug safety affiliates.

Maintained and updated complaint SOP, work practices, job aids and training materials.

Medical affairs associate 04/2016 – 07/2016

Novel laboratory, Inc. / Gavis Pharmaceuticals.

Handled customer calls and ADE reporting.

Managed record of the medical inquiries and ADE information pertaining to signal detection.

Followed up with patients/complainants for additional safety related information.

Completed medical data assessment collection form for ADEs to support filing Medwatch 3350.

Completed allergen statement project for 42 products.

Handled Complaint investigation activities in addition to medical affairs activities.

Pharmacy Technician 11/2015 – 04/2016

CVS Pharmacy; North Brunswick, NJ

Maintained prescription prioritization, prescription processing, SIG code translation, product selection and measurement.

Performed prescription labelling, drug inventory control management and reconciliation.

Co-ordinated third party rejection resolution and manual claim completion.

Provided customer service and provision of product related information to customers.

Complied with CVS quality assurance standards, HIPPA standards, federal and state regulations.

Pharmacist 04/2014 – 01/2015

Ashwini Medical Center, India

Prescription of preparation and medication labeling

Provided product related information to customers and prepared patient prescriptions.

Managed drug inventory control and reconciliation.

Performed prescription related inquiries with primary care providers and specialists.

Pharmacy Technician 09/2010 – 10/2011

Forest Dispensing; Walthamstow, London

Performed packaging, labeling and inspection of drug products.

Managed electronic customer database & compounding oral solutions and creams.

Assisted pharmacist with drug inventory and workflow management and prescription

Provided customer service and provision of product related information to customers

Maintained drug inventory control and reconciliation as per work instruction

Supported blister pack preparation and pharmacy dispensary

EDUCATION

Advanced Drug Safety and Pharmacovigilance; Sollers College; OCT 2017

Master of Science – Toxicology; University of East London; OCT 2010

Bachelor of Pharmacy; Rajiv Gandhi University of Health Sciences; SEP 2008

REFERENCES

Available upon request



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