QA Officer
- Dublin
- Permanent
- Full-time
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.The Role & What You Will Be DoingEvery day, we rise to the challenge to make a difference and here’s how the QA Officer role will make an impact:
- GMP documentation preparation, review, approval and management of D2 system used onsite.
- Participation in training initiatives including preparation and delivery of GMP training modules and any other training modules as required, for plant personnel.
- Preparation of Annual Product Quality Review reports.
- Effective management and control of the process deviation system, including timely preparation of deviation investigation reports.
- Effective management and control of the change control system, ensuring all change controls are approved in a timely manner.
- CAPA management.
- Assisting in preparation for and participation in regulatory and customer audits.
- Generation and reporting of Quality metrics monthly.
- Participation in GMP and Continuous Improvement projects within QA and on site.
- Other duties as required and as directed by the Senior Quality Compliance Manager.
- To perform all activities in accordance with current Good Manufacturing Practice.
- Adhere to the requirements of the Directive 2001183/EC amended by 2004/27/EC and 2003/94/EC and as interpreted in the EC guide to GMP.
- To maintain your place of work in a clean and tidy state at all times.
- To participate in all training and assessment activities. To participate in all SOP training and assessment related to your job.
- To attend all training courses (internal and external), seminars as required for training related to your job.
- In conjunction with the Senior Quality Compliance Manager or designee to ensure all training and assessment is recorded and signed for on your Individual Training Record.
- To adhere fully to all safety policies, procedures and regulations issued by Viatris Damastown.
- To ensure that all work is carried out in a safe manner and any relevant company or environmental legislation is adhered to.
- To immediately notify the appropriate responsible person if you observe a breach of policy, procedure, regulation or potential hazard that could have a serious impact on safety or result in serious personal injury to an individual on site.
- To complete Accident report/Near Miss Forms in a timely manner after an event.
- Bachelor’s degree in Science (equivalent/ related industry experience)
- Relevant experience in a pharmaceutical or other life science organisation.
- The ideal candiate will have previous experience managing deviations, change controls, CAPAs, compiling annual product quality reviews, change management,
- Strong problem solving and attention to detail.
- Good understanding of EU GMP
- Proficiency in speaking, comprehending, reading and writing English is preferred.
- A team player willing to support organisational needs/activities,
- Demonstrated ability to perform in a fast paced enviroment,
- Ability to work independently,
- Experience in TrackWise, MES, SAP, LIMS,
- Proficient in MS Office applications (Word, Excel, Powerpoint etc).