Quality Assurance Coordinator Resume

SUMMARY:

More than 15 years of experience in Quality Assurance and Quality Compliance departments at both local and transnational pharmaceutical companies.
Remarkable experience in documentation control, GMP, GMP Internal and External Audits and Regulatory Compliance.
Knowledge about FDA and EU GMP Regulations.
Knowledge about Manufacturing/Laboratory Deviations, Complaints, Corrective and Preventive Actions reporting and investigation.
Ability to analysis of data for Quality KPIs and metrics reporting.
Ability to work on complex Quality Projects.

SKILLS:

Ability in writing and investigate deviations and corrective/preventive actions

Excellent communication and interpersonal skills.

Strong supervisory and team management skills.

Problem solving capabilities.

Organized and strong eye for details / Can work independently.

Able to work against deadlines.

COMPUTER SKILLS:

Microsoft Word, Excel, Power Point and Outlook.

TrackWise Software (Compliance Monitoring).

QxPERT Software (EDMS).

LabWare LIMS Software (for Quality Control Analyses).

PROFESSIONAL EXPERIENCE:

Confidential

Quality Assurance Coordinator

Responsibilities:

Responsible of Daily Inspections to assure GMP, HACCP and SQF requirements fulfillment in the manufacturing plant.
Documentation Control (SOPs, Records and Support Documentation) as part of the Quality Mangement System.
GMP Program Coordinator.
Batch Record Review for Finished Product Release.
CAPA initiation as per observations found in Daily GMP Inspections.
General oversight of the manufacturing plant operations.

Confidential

Quality Compliance Associate

Responsibilities:

Responsible for communication between Local and Regional/ Corporate Compliance Departments (language and information supporting).
Responsible for QxPERT (local EDMS) configuration, main usage, overview and administration, documentation control and user support.
GMP Program Administration (responsible for programation, coordination and metrics).
Quality KPIs and Metrics Monthly Analysis and Reporting.
Teva Corporate Policies review; gap identification; CAPA opening, monitoring and closure; requirements implementation and final report to Headquarters.
Local and Regional Quality Council Coordinator.
Deviations and Corrective/Preventive Actions opening, investigation, monitoring and closure.
GMP Internal Auditor.
Local Regulatory and Corporate Risk Assessment GMP Audits Readiness Coordinator.
Local Data Integrity Coordinator.

Confidential

Project Manager

Responsibilities:

Responsible for on time implementation of LabWare LIMS software for the Quality Control Laboratory as per Corporate Project Plan (Finished Products, Raw Materials and Packaging Components Modules).
Responsible to supervise and manage the local project team (5 people).
Milestones reporting to Local, Regional and Corporate Directions.
Peru Project was considered one of the best LIMS implementations in Teva worlwide.

Quality Assurance Associate

Confidential

Responsibilities:

Part of the leadership team during the merger process of the Quality Units from Corporacion Medco and Corporacion Infarmasa into Confidential .
Direct reporting to Country Head of Quality.
Local EDMS and GMP Program Administration.
Communication between Local and Regional QA Departments.

Quality Assurance Assistant

Confidential

Responsibilities:

Local EDMS and GMP Program Administration.
Good Storaging Practices coordinator (requirements implementation, responsible for internal and external Audits).
Assisted in Internal, External and Regulatory GMP Audits.

Confidential

Quality Assurance Assistant

Responsibilities: