Description
A leading generic pharmaceutical company based in Dublin is seeking a Quality Specialist to join their team for a 12 Month contract.Job Responsibilities:
Deviation/Change Control/APR completion:
- 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 in APTL performance.
- 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, APR, and other) APTL is responsible for.
- Provides oversight for the analysis of Customer Complaints and reporting for APTL and assures timely completion.
- Authors and ensures timely completion of Change Controls, Action Requests, and Change Control related commitments for APTL .
- Carries out SME role on QA aspects of process owned by APTL.
- Facilitates the management of the APR process as required.
Monitoring Trends:
- Monitors trends in quality parameters, Deviation and Change Control presenting recommendations to the APTL 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) to prepare trend reports.
Participation in Process Improvements:
- Applies cGMP knowledge to recommend action plans to the APTL 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.
Key Attributes:
KNOWLEDGE
- Detail oriented, approachable, and collaborative.
- Knowledge of Quality Management Systems in pharmaceutical and related industries.
- Proven communication skills.
- Experience in problem solving, process improvement techniques, project management is desired.
- Knowledge of cGMP requirements.
EXPERIENCE
- Minimum 3 years Pharmaceutical experience.
- Quality Management system support.
- Quality Assurance and Risk Management.
- Bachelor's degree in science is preferred. Associate degree with appropriate experience will be considered.
This is a great opportunity to gain a wealth of experience in a leading generic pharmaceutical company.
If you are interested in this role and have the appropriate skill set and experience please contact me Anna Mooney or apply below with an up to date CV.