Quality Control Technician

Orion Group Life Sciences are currently recruiting a Quality Control Technician on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend. Days role no shift.

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.
• Participate in driving a high performing & inclusive culture, stimulating personal growth & development may be required to perform other duties as assigned.
• 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

 
About You:

• 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

 
Quality

• 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.

 Delivery

• 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.

 
Site Business Area Support:

• 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.

 
Quality Control:

• Support the Sample Management team members completing day to day activities, as applicable.

Compliance Responsibilities:

• 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/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.

 Typical Minimum Education:

• Leving Certificate or other relevant experience.

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.