- Learning Tai Chi
- Studying Spanish
- Hiking and nature exploration
- Travelling and experiencing new cultures
- DIY and Home Improvement
Danielle Christou
Niddrie,VIC
Summary
Dynamic and results-driven pharmaceutical professional with over 15 years of experience spanning regulatory compliance, quality control, and manufacturing. Proven success in leading critical labelling projects, managing stability trials, and ensuring timely product approvals across global markets. Skilled in stakeholder engagement, process optimisation, and training teams to enhance operational efficiency and performance. Known for strong attention to detail, complex problem-solving abilities, and a proactive, collaborative approach. Committed to continuous learning and bringing a positive, solutions-focused mindset to every challenge.
Overview
25
25
years of professional experience
Work History
Global Labelling Associate
CSL Seqirus
08.2021 - Current
- Collaborated with cross-functional teams and key internal/external stakeholders to ensure timely delivery of critical regulatory labelling projects.
- Performed quality checks on regulatory submission documents to ensure accuracy and compliance with health authority standards.
- Prepared response documents addressing health authority queries, supporting successful product approvals.
- Developed and maintained Standard Operating Procedures (SOPs) and Work Instructions to ensure process consistency and regulatory compliance.
- Led onboarding and training sessions for new team members; provided ongoing support and training to regional regulatory teams to ensure adherence to artwork timelines and processes, particularly ahead of Annual Strain Updates (ASU).
- Managed post-approval activities, including notifying TGA and Medsafe of updates to Product Information (PI), Data Sheets (DS), and Consumer Medicine Information (CMI).
- Acted as a subject matter expert in artwork development for new products, ensuring designs met regulatory requirements across AU, NZ, EU, US, and CA.
- Coordinated the development and delivery of printed materials in a fast-paced environment to meet artwork deadlines for ASU campaigns.
- Utilised GLAMS and PromoMats Production systems to manage artwork lifecycle, ensuring version control, compliance, and timely approvals across global markets.
Quality Control Specialist
CSL Seqirus
04.2017 - 08.2021
- Managed Stability Trials for Influenza Vaccines and Antivenom products, ensuring compliance with ICH guidelines and regulatory standards.
- Conducted data analysis and tending to monitor released batch stability, accurately updated Data Summary Tables
- Initiating and completing deviation actions and change controls in Trackwise, contributing to continuous improvement and regulatory compliance.
- Authored Stability Trial Protocols and Reports in alignment with ICH and regulatory guidelines
- Set up and maintained stability trials in LIMS/GLIMS, ensuring traceability of test schedules and integrity throughout the product lifecycle.
- Oversaw product retention programs.
- Generated Certificates of Analysis to support product release.
- Updated controlled documentation through EDMS, maintaining version control and audit readiness.
- SAP trained - Work order management and raising maintenance notifications
Immunochemistry Team Leader
CSL Behring
09.2012 - 04.2017
- Oversaw daily laboratory operations, ensuring team adherence to GMP, GLP and safety standards.
- Implement process improvements, enhancing workflow efficiency and productivity.
- Trained and mentored new team members on SOPs operational and best practices, fostering a culture of compliance and continuous learning.
- Coordinated scheduling and resource allocation to optimise team performance and meet testing deadlines.
- Led instrument qualification activities (IQ/OQ/PQ/URS)
- Laboratory documentation development
- Conducted root cause investigations of OOS/OOT results, implementing corrective actions to prevent recurrence.
- Raised and closed out deviations and change controls using trackwise.
- Reviewed and released test results, ensuring accuracy and compliance with specifications.
- Liaised with internal and external stakeholders to ensure alignment on testing priorities and timelines.
- Monitored control trending, identifying early signals of process variation and initiating proactive measures.
- Conducted internal audits for GLP compliance and 5S practices, assisting in the closure of audit findings.
- Managed laboratory inventory, ensuring availability of critical reagents and supplies without overstocking.
Immunochemistry Analyst
CSL Behring
05.2010 - 09.2012
- Executed Purity, Potency, Blood and Endotoxin assays to support product release and stability testing of biological products.
- Developed and maintained laboratory documentation, including SOPs and protocols, ensuring compliance with GLP/GMP standards.
- Monitored stock and supply levels, ensuring uninterrupted laboratory operations and timely replenishment of critical reagents.
- Archived training records, assay testing and logbooks in accordance with company data retention policies, ensuring traceability and audit readiness.
- Participated in method validations for routine testing, supporting assay robustness and regulatory submissions.
- Served as Laboratory Chemical Coordinator, conducting chemical audits and ensuring safe handling and storage practices.
- Coordinating external sample testing of plasma raw material with the red cross blood bank.
- Arranged shipment of product for testing ensuring appropriate permits and documentation were in place for compliant delivery.
Assistant Project Officer
VicHealth
01.2010 - 05.2012
- Maintained and updated in-house GIFTS database system containing project and stakeholder information, supporting accurate reporting and coordination.
- Managed calendars and scheduling for senior staff, ensuring efficient time management and meeting logistics.
- Supported event planning and coordination, contributing to successful delivery of stakeholder engagement activities.
- Managed the budget spreadsheet for the Participation and Equity for Health Unit, supporting financial tracking and reporting.
- Managed the budget spreadsheet for the Participation and Equity for Health Unit, supporting financial tracking and reporting.
- Prepared correspondence to acknowledge receipt and approval of project documentation.
- Coordinated grant payments for approved projects, ensuring compliance with funding.
- Handled Active Club Grant enquiries and processing, providing support to applicants and stakeholders.
- Managed large-scale mail outs, ensuring timely distribution of communications and materials.
- Collated, proofread, and formatted Board papers, ensuring clarity and consistency for executive review.
Influenza Technician - Manufacturing
CSL Seqirus
01.2009 - 08.2009
- Operated in a GMP manufacturing environment to produce influenza vaccines for both the Southern and Northern Hemisphere markets.
- Followed SOPs to ensure production met FDA and TGA audit standards and regulatory requirements.
- Managed weekly rosters for 55 staff members, ensuring efficient shift coverage and operational continuity.
- Completed and maintained batch process sheets, supporting documentation accuracy and compliance for product release.
Technical Coach / Call Centre Operator /Office Administrator
ANZ Banking Group
03.2001 - 01.2008
- Delivered high-quality customer service, handling enquiries related to account details, products, and lost or stolen cards.
- Provided technical coaching and support to team members, helping staff improve productivity and quality, resulting in improved monitoring scores.
- Trained staff on updated work procedures and company policy changes, ensuring consistent service delivery and compliance.
- Monitored staff performance and quality, ensuring correct processes were followed and accurate information was provided to customers.
- Handled escalated calls from staff, resolving complex customer enquiries at first contact.
- Drafted written correspondence to customers via email and letter, addressing complaints and enquiries professionally.
- Performed a range of administrative duties, using multiple in-house systems to assist staff and manage customer records.
- Processed fax requests for emergency card embossing, requiring strong attention to detail and time management to avoid delays.
Education
Bachelor of Science - Animal And Veterinary Biosciences
La Trobe University
Bundoora, Victoria, VIC01-2008
Skills
- Customer service
- Time management
- Attention to detail
- Computer skills
- Leadership qualities
- Complex Problem-solving
- Work Planning and Prioritisation
- Multitasking in High-Volume Environments
- Verbal and written communication skills
- Stakeholder engagement
Interests
Timeline
Global Labelling Associate
CSL Seqirus
08.2021 - Current
Quality Control Specialist
CSL Seqirus
04.2017 - 08.2021
Immunochemistry Team Leader
CSL Behring
09.2012 - 04.2017
Immunochemistry Analyst
CSL Behring
05.2010 - 09.2012
Assistant Project Officer
VicHealth
01.2010 - 05.2012
Influenza Technician - Manufacturing
CSL Seqirus
01.2009 - 08.2009
Technical Coach / Call Centre Operator /Office Administrator
ANZ Banking Group
03.2001 - 01.2008
Bachelor of Science - Animal And Veterinary Biosciences
La Trobe University