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Quality Assurance Professional
3 weeks ago
The role of the QA Officer is crucial in ensuring the quality and compliance of our products. We are seeking a highly motivated and experienced professional to join our team as a QA Officer.
Responsibilities:
- Manage GMP documentation, reviews, approvals, and management of D2 system used onsite.
- Participate in training initiatives including preparation and delivery of GMP training modules and other training modules as required for plant personnel.
- Prepare Annual Product Quality Review reports.
- Effectively manage and control the process deviation system, including timely preparation of deviation investigation reports.
- Effectively manage and control the change control system, ensuring all change controls are approved in a timely manner.
- Manage CAPA.
- Assist in preparation for and participation in regulatory and customer audits.
- Generate and report Quality metrics monthly.
- Participate in GMP and Continuous Improvement projects within QA and on site.
- Perform all activities in accordance with current Good Manufacturing Practice.
- Adhere to the requirements of the Directive/EC amended by 2004/27/EC and 2003/94/EC and as interpreted in the EC guide to GMP.
- Maintain your place of work in a clean and tidy state at all times.
- Participate in all training and assessment activities.
- Attend all training courses (internal and external), seminars as required for training related to your job.
- Ensure all training and assessment is recorded and signed for on your Individual Training Record.
- Adhere fully to all safety policies, procedures, and regulations issued by Viatris Damastown.
- Ensure that all work is carried out in a safe manner and any relevant company or environmental legislation is adhered 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.
- Complete Accident Report/Near Miss Forms in a timely manner after an event.
