Remediation Project Associate resume example with 14+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Professional Summary
9 years Pharmacy company Quality Department working experiences. Be familiar with tablet, sterile, capsule and cream product.
Licenses
Skill Highlights
CET 6
Professional Experience
01/2015 to Current
Remediation Project AssociateGSK Aiken – City, STATE,
Work with Remediation Lead to implement remediation project to help site get out of remediation.
Work with team member to set up site Quality Management System according to GSK's quality system.
Lead team meeting and attend steering meeting when absent of Remediation Leader.
Facilitate site to complete all gap analysis against GSK's Quality Management System documents.
08/2014 to 2015
Action Head of QualityGSKT – City, STATE,
Provide leadership to ensure GSKT manufacturing processes, operations and activities related to quality comply with GSK Quality standards and regulatory requirements in supplied markets.
Work closely with Production and other functional managers to ensure compliance with GMP and relevant regulatory guidelines.
Oversee the Quality Assurance, Regulatory, Validation, Documentation and Quality Control functions within the Quality Department to ensure that appropriate systems are in place to satisfy GSK quality standards and regulatory requirements in supplied markets.
Lead and manage the site Quality & Regulatory team, including driving the Quality strategy, setting objectives, priorities and metrics.
Establish and implement a robust quality system for batch release.
Ensure all the significant deviation and OOS is investigated and get timely managed.
Ensure all the complaints related to product quality get investigated and get timely and properly dealt with.
Ensure that raw materials, packaging materials, intermediate products, bulk products and finished products comply with the registration requirements and quality standards approved.
Ensure the completion of inspection plan of product stability, provide the data of inspection about stability Provide leadership to improve the Quality Assurance, Auditing and Reporting Program to ensure closure of corrective actions and prevention of recurrence.
Set up an effective change management and validation system to ensure the suitability and reliability of production operation.
Ensure Quality standard of new products registered comply with GMP, regulatory, and GSK quality requirements.
Responsible for Department people development, improve employee engagement; Ensure a robust and credible succession plan is in place for all key roles within Quality.
Oversee the technical investigation of all product complaints and returned goods to minimize patient risk.
Assess and approve materials suppliers.
Confirm the monitor the storage condition of materials and products.
Oversee the registration of site products together with GSK China RA team / international Regulatory Affairs to ensure regulatory conformance.
Be responsible for Risk management system.
Supervise facility and equipment's maintenance and in good operation conditions Develop and mentor direct reports.
Manage the Quality Assurance Department within Budgets, Headcount, Facilities, EHS compliance and Expenditure Limits as agreed with Site Director.
05/2012 to 10/2014
GSKT RC&QMS Section Manager – , ,
Deal with all issues with domestic and oversea markets regulation cases.
It is including change control assessment, market license renew, issue CPP etc.
Work as QMS Champion to coordinate site set up and maintain quality management system as GSK QMS.
Coordinate site set up and maintain quality system as China GMP and EU GMP as well.
Set up and maintain site L1/L2 audit including prepare audit universe, audit schedule, training L1/L2 site auditors.
Work as site level 2 auditor since Y2009.
I'm in ACP training now and already lead 4 level 2 audits.
Coordinate A&A audit and work as host during audit.
Lead regulation inspection readiness and faced regulatory inspections from China, MHRA, Brazil, Argentina*Mexico and Japan.
Work as host during the regulation inspections.
Work as site SCTPO to set up and maintain compliance training system.
Set up packaging material specification.
My function was ever took charge of supplier management system including supplier qualification, supplier profile setup, supplier complaint management.
My function was ever took charge of risk management and I was worked as risk coordinator to maintain and develop site risk management system with RMPO.
06/2006 to 03/2012
OQA Specialist and Acting OQA Section ManagerNA – City, STATE,
On-line inspection including in-process monitoring and validation activity monitoring of tablet and sterile product.
Deal with change control, deviation, customer complaint, repack, rework and reprocess etc. of products.
Review and approve product batch record and relevant SOPs.
Work as QP delegation to release product.
Annual GMP training and train SOP to employee.
Conduct periodic product review.
Take charge of site change control system and deviation management system.
Education and Training
Expected in 2006
Bachelor: Bioengineering Dalian University of Technology - , GPA:
Bioengineering
Community Service
Accomplishments
2013 /12--2014/08
Project Description:Improve internal audit efficiency, including indicator set up for tracing of completion of audit, reduce corrective and preventive action reoccurrence, reduce findings from group and market regulation inspection and qualify much more internal auditors.
Responsibility:I work as a project leader and involve all site functions/internal auditors.
________________________________________
2010 /10--2012 /4:Reduce product release leading time
Project Description:Analysis data from each release step, utilize OE tools to lean and improve. Coordinate each related department reduce leading time from 30 days to 4 days.
Responsibility:Work as the function manager to support department staff. After the staff left company, lead the project.
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2010 /4--2010 /8:100% adherence of line clearance simulation
Project Description:Review all production area/line clearance risk points and conduct FMEA to category risk points rank. Area/line clearance simulation will be follow the FMEA result and standard work. The project purpose is 100% adherance of simulation and keeps improving clearance performance.
Responsibility:Lead the project and coordinate with production and planning to complete the project.
________________________________________
2009 /10--2009 /12:Lean Change Control System
Project Description:Optimize change control process covers raising, assessing, approving and closing process.
Responsibility:Support department section manager to collect data at the beginning of the project. Now, I have taken the responsibility to improve the performance of the project.
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2008 /5--2008 /5:Lean Deviation Process
Project Description:Enhance the investigation process of deviation management.
Responsibility:Support department section manager to complete the project.
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2006 /12--2007 /3:Information Security System
Project Description:Establish a security system to control all information in site. The system covers the information from generated, approved, implemented, distributed, retrieved and destroyed.
Responsibility:As a project leader to coordinate document coordinator from all department to complete the project.
Languages
Fluent written and oral English.
Skills
Auditing, Budgets management, project management, oral and written English
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