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Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives worldwide. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact felt within healthcare and beyond.
We are now recruiting a Quality Compliance Technician to join our diverse Quality team in Westport on a 1-year fixed-term contract basis.
As our new Quality Compliance Technician, you will support the Quality and Compliance Lab group and take responsibility for all QA activities across the ATL (Analytical Technical Laboratory) and Microbiological laboratories. In this role, you ensure that QA support is provided across both laboratories as deemed necessary.
In your new role you will need to have in-depth knowledge in Microbiology and Aseptic Processes such as Bioburden Test Methods, Endotoxin Test Methods, Sterility Test Methods, Cleanroom Environmental Monitoring programs and standards, applications and adherence to Annex 1 of the EU GMPs. You will be responsible for assisting with test method development and validation in accordance with Company requirements, Pharmacopeial and Regulatory standards. There is a wide range of chemistry analysis and the compliance team need to be familiar and knowledgeable with the test methods performed within the ATL such as impurity and leachable/extractable analysis through HPLC and GC chromatographic testing, dissolution, and all raw materials testing.
Is this a team you want to be part of? Then read on…
• Provide quality input as required, assisting day to day activities, including completion of quality records and RCPS activities.
• Collaborate with the department on the adherence to company quality rules and global regulatory requirements for the laboratories
• Foster an environment of continuous improvement for the area by identifying and highlighting efficiencies and quality improvements.
• Support laboratory changes/validation projects where QA input is required.
• Collaborate with Laboratory teams to ensure the site and global quality metrics are achieved by processing records and documentation on time.
• Maintain strong relationships with the Laboratory Management, Supervisors and Analysts. Articulate the necessary quality requirements in a clear, concise and persuasive manner.
• Demonstrate active support and involvement in the successful progress of compliance initiatives to enhance the site quality program.
• Partake in the site or department inspections as required.
• Attend Root Cause Analysis (RCA) meetings organized by the record owners.
• Third Level Science qualification or equivalent
Technical Skills and Experience:
• Proven Track record in a quality discipline in the Pharma/Medical Device environment
• A clear understanding of working within a regulatory environment
• Excellent communication skills
• Ability to use sound judgement to make effective decisions within appropriate timelines
• Proven to be self-directed, self-motivated and able to prioritize competing priorities
• Knowledge of laboratory GMP standards
• Experience with Laboratory and company IT systems such as Global Track Wise (GTW), OneVault, LIMS etc
AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
Job Type: Temporary Work