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.
Key Responsibilities:
* Perform QC assignments for Carlow quality systems, processes, and controls.
* Accountable for contributions to ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety, and reliable customer supply.
* Respond to Operational and business areas, ensuring compliance with cGMP and corporate regulations.
* Support the performance of site cGMP activities.
* 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 oversight) as per business needs.
* Provide support to the relevant support functions to ensure manufacturing and release activities, in compliance with applicable procedures, the 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.
* Respond 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.
* Support the Laboratory and team members with day-to-day activities, as applicable.
* Ensure compliance with regulatory requirements.
* Assist team members with tasks relating to SOPs, 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.
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