Permanent full time
Flexible working hours
Salary: €42,000 Negotiable plus excellent benefits package
Deviation/Change Control/Regulatory Compliance
- Ensures relevant regulatory information is available for product release
- Liaising with local and external affiliates to ensure regulatory compliance at manufacturing sites is maintained.
- Initiating and managing regulatory compliance remediation activities to ensure registered information complies with manufacturing site practices
- Initiates, authors, and possibly assist in approvals of deviations ensuring they contain the essential elements necessary to assure continuous product and process compliance and improvement. Assures completeness in terms of root cause, action taken, and preventative measures.
- Authors, tracks, and/or ensures timely closure of commitments (Regulatory Agency, investigation, audit, PQR, and other) is responsible for.
- Provides oversight for the analysis of Customer Complaints and reporting and assures timely completion.
- Authors and ensures timely completion of Change Controls, Action Requests, and Change Control related commitments.
- Carries out SME role on QA aspects of process. Participates in SOP preparation as such.
- Facilitates the management of the PQR process as required
- Monitors trends in quality parameters presenting recommendations to management to maintain process under control and/or to further improve the process.
- Utilizes systems (e.g., Trackwise,) and applies tools (i.e., SPC, Six Sigma, DMAIC) to prepare trend reports.
Participation in Process Improvements
- Applies cGMP knowledge to recommend action plans to the teams supporting process improvements.
- Provides data on quality parameters, Deviations and Change Control trends to support continuous improvement.
- Links with the quality management to facilitate the implementation of Group wide initiatives.
- Managing Project, where required
- Adherence to Company Health & Safety procedures
- Participate in training programmes
- Any other duties as assigned by your Manager
- Previous experience in a similar Quality role ideally within the pharmaceutical and/or related industry
- Results and performance driven – deliver results that meet or exceed expectations
- Sense of urgency – responding to issues and opportunities in a timely manner
- Take ownership and accountability for activities
- Positive and pro-active approach to business tasks
- Ability to lead and support several concurrent projects/products and develop strong relationship within cross-functional teams.
- Positive ‘can – do’ attitude
- Be able to work autonomously and have good problem solving skills.
- Highly driven with enthusiasm to meet role requirements and to cope under demanding pressure
- Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business
- Ability to influence and partner with cross-site teams in a global pharmaceutical organisation
- Execution – persistent drive for results utilising sound project focus, organisational and problem solving skills.
- Enthusiasm and Drive to take complete ownership and drive process improvement initiatives.