Carine Labuscagne

• Maintaining validation and calibration schedules while liaising with contractors.
• Prepare validation documentation to meet 21 CFR Part 11, WHO, SAHPRA, GMP, GWP, GDP, etc; Plans, Protocols and Reports
• Ensure assigned validation exercises are conducted in a timely manner and in compliance with GWP and project milestones.
• Participate in Change Control assessments and project meetings to ensure the compliant status of affected equipment is not compromised.
• Participate in corporate, regulatory and internal audits as necessary.
• Focus on Computer, facility and transport validation studies and maintain GWP compliance at all times.
• Managing of site validation documentation and completion of validation risk assessments.
• Preparation and Review of Departmental SOPs.
• Work with QA, Operations, Maintenance and other departments to resolve audit findings.
• Working knowledge and practical experience with equipment qualification (RA, URS, DQ, IQ, OQ, PQ and PR) protocol and report compilation
• Proven industry experience in validation ideally within a GWP distribution environment

Key duties and responsibilities:

• Facility Validation
• Transport Validation
• Risk Analysis
• Effectiveness check reviews
• CAPA Reviews
• Computer system Validation

• Developed team communications and information for meetings.
• Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
• Actively listened to customers, handled concerns quickly and escalated major issues to supervisor.
• Learned new skills and applied to daily tasks to improve efficiency and productivity.
• Created plans and communicated deadlines to complete projects on time.
• Prepared variety of different written communications, reports and documents.

· Formulated and managed Internal Communications, which include the following communications channels: LCD screens nationally, Internal Newspaper, Intranet.

· Responsible for sourcing, writing and editing of all internal communication material before it is published

· Coordinating and organising Internal and External events, promotions and conferences

· Managing Internal Communications budget

· Interacting with internal stakeholders on all levels including Managerial and Executive level

· General Administration duties – managing the office stationery, printer, assets, etc.

· Managing Communications Assistant, including performance management and development

· Managing Internal Communication budget

· Won company award for going the extra mile

· Excellent attention to detail, ability to set goals and coordinate multiple tasks.