Quality Systems Project Coordinator

LAWRIE MELTON

STONEY CREEK ONTARIO

Cell: 905-***-****

E-mail: *********@*****.***

http://ca.linkedin.com/in/lawriemelton/

CAREER SUMMARY

Performance driven and detailed oriented Quality Systems Specialist & Project Coordinator with solid practical knowledge of the sterile pharmaceutical industry. Known for being an extremely efficient professional capable of coordinating multiple conflicting priorities/projects at local/global levels while adhering to stringent timelines. Takes initiative to drive large complex tasks to completion. Dedicated and loyal employee with strong people, communication and leadership skills. Key expertise:

Document Review

Audit Management

Aseptic Practices

Process Improvement

Project Coordination

GMP

Leadership

Organization

Microsoft Office

PROFESSIONAL EXPERIENCE

CIBA VISION CANADA INC. (A Novartis Company)

Quality Systems Associate / Quality Improvement Project (QIP) Coordinator (2003 –Present)

Accountable for implementation of Quality Systems through quality plans, risk assessments and system reviews and coordination of major projects to implement Novartis Quality Modules into the procedures and practices of the site;

Quality Systems:

Managed site’s Key Performance Indicators for monthly reporting to global ensuring accurate representation of site goals.

Participated in creation of annual Quality Plans and facilitated reporting of Quality plans on a quarterly basis to site and global Quality team to clarify the site’s progress on quality objectives.

Part of Local Change Review Board as a Quality advisor, ensuring all regulatory requirements are satisfied for requests submitted.

Acted as a Quality Representative on risk assessment projects thereby implementing continuous improvement.

Reviewed and approved Standard Operating Procedure revisions, ensuring changes submitted are compliant to regulatory requirements.

Performed root cause analysis on incidents and implemented corrective/preventive actions focussed on prevention of future reoccurrences.

Managed open CAPA’s and provided regular reporting to ensure accountability and timely closure.

Audits:

Managed audit preparation activities for all corporate and regulatory audits by gathering and maintaining documentation, thereby facilitating speedy document retrieval, traceability and ensuring compliance.

Performed walkthroughs of departments to prepare for external audits, ensuring audit readiness.

Monitored audits CAPAs to ensure timely and compliant closure of action items.

Project Coordinator:

Coordinated the Novartis Quality Improvement Project by setting up functional teams to identify and remediate process gaps thereby bringing the site up to Novartis Global Standards and surpassing industry standards.

Acted as a project advisor/mentor to team members by providing ongoing support, maintaining team morale and focus thereby building a strong productive team.

Acted as a liaison between the site and the Global project team to bring global modules into the site and provide progress reports, ensuring global expectations are fulfilled.

Maintained a Microsoft Project Plan of over 2000 items which better enabled the organization of project assessments and remediation activities.

Maintained a global project plan reporting deliverables, status and timelines, providing transparency of site progress to Global project team.

Represented the site during Global project audits, conveying the site’s high level of compliance to Novartis standards through the successful execution of the project requirements.

Quality Assurance Inspector / Release Authority (1995-2003)

Hands on quality inspector working on the production floor to perform all quality inspection activities as well as off floor activities such as deviation investigations, product defect inspections and record review;

Conducted line approvals and clearances, supervised on line inspections, ensuring product complies with batch requirements.

Provided quality direction to packaging associates, thereby promoting a quality culture within the production work force.

Ensured all batch requirements and industry regulations were met by effectively performing batch record reviews.

Performed Annual Product Reviews (APRs) by reviewing historical data to identify negative trends which allowed for future product sustainability.

Reviewed batch records for commercial release, ensuring adherence to legal and regulatory standards

Previous Positions

Cleanroom Blow Mould Operator, Clean Room Filling Operator, Packaging Operator

PROFESSIONAL DEVELOPMENT

Aseptic Processing Workshop (AAPS)

Root Cause Analysis for CAPA (IPA)

Project Management (Schulich Executive Education Centre)

Fundamentals of Successful Project Mgmt (Skillpath Seminars)

Leadership Development Program (Development Dimensions International)

Managing Multiple Project, Objectives and Deadlines (Skillpath Seminars)

Global GMP Update (IPA)

Microsoft Excel Training (Surtel & Associates)

COMPUTER SKILLS

TrackWise, Microsoft Office (Excel, Project, Word, Outlook, PowerPoint), Visio, SharePoint

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