Ciara Condit Email & Phone Number

Australia

Sydney, New South Wales, Australia

- Manage the Change Control Program, overseeing the evaluation, approval, and execution of all change requests in accordance with regulatory requirements and company policies.- Collaborate with cross-functional teams to assess the impact of changes on product quality, processes, and compliance, ensuring minimal disruptions.- Pivotal role in completing Annual Product Quality Reviews (APQR), conducting thorough data analysis, trend assessments, and documentation to ensure product quality and regulatory compliance.- Protocol and procedure approval, reviewing documentation for compliance with established specifications and regulatory standards.- Developed and maintained comprehensive QMS metrics, reports to facilitate continuous process improvements.- Successfully prepared and navigated through regulatory inspections and audits, maintaining a culture of audit readiness.- Managed the end-to-end complaint handling process, including investigation, risk assessment, documentation, resolution, and reporting.- Supported the development and implementation of Standard Operating Procedures (SOPs) related to QA processes.- Managed artwork, document and investigation management ensuring regulatory compliance. - Conducted internal audits and collaborated with audit team, assessing for compliance issues and continuous improvement opportunities. - Facilitated effective communication with external customers, managing change controls and quality agreements.- Established relationships with vendors to coordinate artwork updates. - Manage vendor change notifications, escalate to relevant stakeholders where required.

Sydney, New South Wales, Australia

- Managed equipment calibration, commissioning, and maintenance activities, ensuring all laboratory instruments met regulatory and quality standards.- Maintained open communication with external vendors, negotiating service contracts and coordinating equipment repairs and maintenance.- Managed the qualification and implementation of new software used in laboratory operations, guaranteeing compliance with CFR 21 Part 11 industry regulations and data integrity standards.- Oversaw laboratory stock management, maintaining inventory levels, and ensuring the availability of necessary supplies for smooth operations.- Conducted thorough data review and approval, verifying the accuracy and compliance of analytical results.- Collaborated with cross-functional teams to address quality-related issues, implement corrective actions, and maintain a culture of quality excellence.

Sydney, New South Wales, Australia

- Authored comprehensive Out-of-Specification (OOS) investigations and deviation reports, demonstrating strong analytical and problem-solving skills.- Conducted meticulous review and approval of analytical data, assigning appropriate product disposition, ensuring product quality and regulatory compliance.- Wrote stability protocols, defining testing parameters, and timelines to assess product stability over time, in alignment with industry standards.- Executed validation protocols for analytical methods, ensuring their accuracy and reliability.- Authored qualification protocols for new equipment and software packages, facilitating their integration into the laboratory.- Developed Standard Operating Procedures (SOPs) for laboratory equipment and processes, promoting consistency and compliance within the organisation.

Sydney, New South Wales, Australia

- Conducted HPLC analysis, data analysis and generated stability protocols for product evaluation.- Utilized wet chemistry techniques for sample analysis.- Collaborated with QA team to implement corrective actions based on stability testing results.

Sydney, Australia

• Perform QC, Stability and Development testing on in-process and finished products.• Enter data, review results & statistically analyse and trend data to assist with batch release.• Write, review and identify improvements for Procedures, Methods & Protocols.• Write and review reports for Development & Validation.• Perform document checks, calibrations and qualifications• Experienced testing inhalation products by DU, ACI & MSLI • Work to TGA & GMP regulations, Working knowledge of QMS and Document Control system

Newry County Down Northern Ireland

• Testing compliance of chemical raw materials to EP, BP, JP & US pharmacopeia whilst adhering to GMP and GLP. • Follow SOP’s, Health & Safety procedures and Safety Data Sheets• Work under pressure to meet deadlines • Perform water quality analysis from various sample points & cooling towers• Use wet chemistry techniques: TLC, titration, functional group identification test, limit test• Instrumental analysis including Particle sizing (Malvern 3000/Beckman Coulter), KF moisture determination, UV absorption, FTIR & NIR identification, pH, polarimetry and auto-titration • Perform and interpret HPLC, UPLC (Waters & Agilent) and GC analysis (Agilent & Perkin Elmer)• HPLC maintenance, calibration & trouble shooting• Develop QC procedures to maintain good manufacturing practice and monitor quality • Practised in accurately collating, recording and interpreting scientific data• Trained in the safe handling of hazardous chemicals• Responsible for training new analysts, drawing up weekly schedules, maintaining training files• 5 S environment