Quality Assurance Specialist

📋 Description

• Assist and implement quality oversight activities for Clinical Trial Materials produced at external Contract Manufacturing Organizations (CMOs).

• Ensure the consistent application of quality compliance by aligning daily operations with relevant cGMP regulations (US, EU, and other necessary regions).

• Evaluate batch documentation, supporting data, certificates of analysis, and technical reports for Finished Drug Product, clinical packaging, and labeling.

• Aid in batch disposition processes in accordance with established quality procedures and regulatory standards.

• Facilitate and assist in deviation investigations, change controls, CAPAs, inquiries, and nonconformance activities related to clinical manufacturing and external supply.

• Engage in inspection readiness activities and provide support for internal, vendor, and regulatory audits and inspections.

• Identify, evaluate, and escalate product-related quality and regulatory concerns, as well as emerging trends.

• Collaborate closely with Clinical Supply, Regulatory Affairs, Technical Operations, external Qualified Persons (QPs), and other stakeholders involved in external manufacturing and supply.

⛳️ Requirements

• Bachelor’s degree in a relevant field.

• A minimum of 3 years of pertinent QA compliance and/or Quality Product Disposition experience within the pharmaceutical or biotech sector.

• Proficient understanding of cGMP regulations.

• Experience in reviewing manufacturing or clinical documentation.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance options tailored to you and your family’s needs.

• Competitive retirement planning options to enhance savings and help you plan confidently for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting you and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.