Quality Technician II

Aphex Group; Carlow; On-site; EUR 42,000 - 60,000; Full time

Job summary

Aphex Group in Carlow, Ireland, is seeking a Quality Assurance/Compliance professional to ensure CGMP/GDP adherence across day-to-day activities. You will maintain ALCOA data integrity and assist with training, audits and continuous improvement within the Quality and Manufacturing functions.

You will collaborate with Manufacturing, QC and QA teams to support batch release, regulatory compliance and robust quality systems at the site, contributing to a safe, compliant culture and efficient

Qualifications

• Experience with a LIMS (GLIMS experience is an advantage).
• Strong communicator, comfortable working with stakeholders at all levels.
• Able to prioritise and deliver against competing deadlines.
• Collaborative and able to communicate effectively across functions.
• Committed to continuous improvement and operational excellence.
• Leaving Cert or other relevant experience.

Responsibilities

• Coordinate the end-to-end sample lifecycle in GLIMS: receipt, logging, processing, distribution and traceability through to disposal.
• Prioritise and schedule sample workload to meet timelines. Coordinate shipment of samples to external contract laboratories and sister sites.
• Log retain samples in accordance with retain sample management programme. Ensure day-to-day activities meet GMP and regulatory standards.
• Contribute to root cause investigations using structured problem-solving tools.
• Identify and deliver continuous improvement projects that improve efficiency and reliability.
• Partner with Manufacturing, QC, Quality Assurance, External Quality and other stakeholders to meet site goals.
• Liaise with the QC Leads to resolve quality related queries where required.
• 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.
• 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 Sample Management team members completing day to day activities, as applicable.
• Ensure compliance to regulatory requirements.
• Assist team members with tasks relating to SOP's, Deviations and other documents as necessary for the Quality and Manufacturing departments where required.
• Contribute to effective writing/revisiting/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.
• Participate in training programs as required.

Job description

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 human health products. Work collaboratively to ensure a safe and compliant culture in Carlow. Participate in driving a high performing & inclusive culture, stimulating personal growth & development may be required to perform other duties as assigned.

Purpose

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 human health products. Work collaboratively to ensure a safe and compliant culture in Carlow. Participate in driving a high performing & inclusive culture, stimulating personal growth & development may be required to perform other duties as assigned.

Responsibilities

• Coordinate the end-to-end sample lifecycle in GLIMS: receipt, logging, processing, distribution and traceability through to disposal.
• Prioritise and schedule sample workload to meet timelines. Coordinate shipment of samples to external contract laboratories and sister sites. Log retain samples in accordance with retain sample management programme. Ensure day-to-day activities meet GMP and regulatory standards. Contribute to root cause investigations using structured problem-solving tools. Identify and deliver continuous improvement projects that improve efficiency and reliability. Partner with Manufacturing, QC, Quality Assurance, External Quality and other stakeholders to meet site goals.
• 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.
• 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.
• 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 Sample Management team members completing day to day activities, as applicable.
• Ensure compliance to regulatory requirements.
• Assist team members with tasks relating to SOP's, Deviations and other documents as necessary for the Quality and Manufacturing departments where required.
• Contribute to effective writing/revisiting/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.
• Participate in training programs as required.

Requirements

• Experience with a LIMS (GLIMS experience is an advantage).
• Strong communicator, comfortable working with stakeholders at all levels.
• Able to prioritise and deliver against competing deadlines.
• Collaborative and able to communicate effectively across functions.
• Committed to continuous improvement and operational excellence.
• Leaving Cert or other relevant experience.