Quality Technician

Orion Group Life Sciences are currently recruiting a Quality Technician on behalf of our Multinational Biopharmaceutical client based in Sligo on an initial 6-month contract (with potential to extend).

Primary Responsibilities:

• To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved.
• Ensure that all actions comply with current good manufacturing practices.
• Operate within the QC/ IQA and Metrology Areas, as required.
• Complete incoming product testing per the relevant approved specifications and procedures.
• Complete in-process and final release product testing per the relevant approved specifications and procedures.
• Ensure Management is kept informed of all Quality Events or potential Quality Events Related to the product or process.
• Ensure all Quality System documentation is thorough, complete, and compliant.
• Audit the quality system with other personnel where required.
• Support Change Management Process including Product and Quality System document review and updates.
• Generate and providing metrics for inclusion in the management review, monthly reports, and overall Quality Performance.
• Ensure compliance with training requirements is maintained.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
• Generate batch records for as required in support of manufacturing process orders.
• Complete disposition decisions for incoming material.

Education and Experience:

• A third level qualification in an appropriate discipline is desirable.
• 2+ years' Experience within a regulated GMP environment is desirable.
• 1 year plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment is desirable.

Cognitive Skills:

• The position requires a high level of attention to detail and mental concentration, to ensure total compliance with operating procedures and Regulations at all times.
• The position requires the ability to adapt to new processes on a regular basis.
• The position requires total commitment to quality and safety at all times.
• Shows a high level of attention to detail and tenacity to ensure any issues noted are elevated to the Operations Quality Team Leader.
• Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures, and guidelines.
• Shows a high level of attention to detail and tenacity to ensure any issues noted are elevated to the Operations Quality Team Leader.
• Works from the general instruction provided by management personnel in respect of the duties to be performed.
• Ensures any unusual observations or issues noted are reported to the Operations Quality Team Leader
• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.

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.