Want to make a global impact? We offer that.
Want to be part of a Great Place to Work in Ireland? We offer that too.
Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are now recruiting a QC Documentation Controllor to join our diverse Team in Clonshaugh, Dublin. The QC Documentation Controllor is responsible for assisting in the update, management and progression of laboratory documentation through the relevant quality systems to the effective/final state. The role assists with internal audits and reviews calibration and preventative maintenance records. The position incumbent is expected to adhere to all cGMP compliance and regulatory mandates and quality requirements, and comply with all SOPs and internal Forest Laboratories policies and procedures in the performance of job duties. QC Documentation support applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality, and/or the fulfillment of the assigned performance targets. The QC Documentation support is responsible for the safe, compliant, and efficient execution of job duties in a team environment. This position reports to the QC Supervisor and may act as his/her deputy as deemed necessary.
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities as QC Documentation Controllor would be:
• Carry out documentation support as per the agreed schedule.
• To give assistance in maintaining and updating laboratory procedures, test methods, protocols, reports and other laboratory documentation as required.
• Create and/or edit documentation as required and progress through EDOCS.
• To generate and manage the progression of assigned Change Controls and/or CAPAS through TrackWise
• To assist and coordinate training activities associated with the introduction or update of documentation
• To maintain the QC Training Matrix
• When necessary to participate in training programmes.
• Seek process innovation and continuous process improvement.
• Complete and conform to all training requirements for job role, including company-required and job role-specific training.
• Carry out and assist in the ongoing training of new and existing personnel, as appropriate.
• Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses
So, what do you need to do this role?
Education & Experience
• 2-3 years relevant Quality Control experience or equivalent combination of education and experience
• Experience in pharmaceutical manufacturing facility.
• Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
• Experience and a good working knowledge of software packages such as EDOCS and TrackWise
So, are you ready to join our team?
It’s important to remember, 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.