Orion Group Life Sciences are currently recruiting a Quality Technician on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-month contract.

• Performs QC assignments for Carlow quality systems, processes and controls.
• Accountable for contribution to ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety & reliable customer supply.
• Responds to Operational and business area’s, ensuring compliance with cGMP and corporate regulations.
• Support the performance of the site cGMP activities.

 
Key Responsibilities:

• Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
• Attend and successfully complete applicable CGMP training.
• Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products.
• Work collaboratively to ensure a safe and compliant culture in Carlow.
• Liaise with the QC Leads to resolve quality related queries where required
• Ensure that adequate processes and procedures are in place and followed for all Quality activities.
• Where required work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery and or oversight) as required as per business needs & if needed.
• Provide support to the relevant support functions to ensure manufacturing and release activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
• Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
• Support business critical projects related to the Quality Department.
• Responds to standard requests and communication processes to allow the flow of appropriate information between departments.
• Use MPS principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
• Sign approved job description.
• Support in resolving routine potential quality issues.
• Provide quality support of controls and procedures for the end to end material and product lifecycle where applicable.
• Assist team members to support the qualification/validation, technical transfers, and commercial operations at the facility where required.
• Supports the Laboratory and team members with day-to-day activities, as applicable.
• Ensure compliance to regulatory requirements.
• Assist team members with tasks relating to SOP's, Deviations, cleaning verification/validation data and other documents as necessary for the Quality and Manufacturing departments where required.
• Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.

 
Qualifications/Education:

• Leaving Certificate or other relevant experience.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.