Blackfield Associates are partnered with a Leading Pharmaceutical Distribution organisation based in Dublin in the search for a Quality Lead/DRP.
As the Quality Lead/DRP, you’ll play a pivotal role in ensuring the effectiveness of the Quality Management System and maintaining compliance with a variety of GMP and GDP guidelines. Your contributions will be essential in safeguarding the quality and integrity of the pharmaceutical operations. Key responsibilities in this role include, but are not limited to:
* Deviation and CAPA Leadership: Take charge of the Deviation and Corrective and Preventive Action (CAPA) process for all quality-related issues. Your expertise will help us address and rectify quality deviations efficiently.
* Regulatory Inspection Support: Collaborate closely with the Responsible Person (RP) and Quality Director to facilitate regulatory inspection activities. Your support will be invaluable in ensuring a smooth interaction with pharmaceutical inspection teams.
* Audit Analysis and Recommendations: Analyze audit findings and provide insightful recommendations to management. Your guidance will aid in identifying areas that may require additional staff training, enhanced documentation, or process improvements to maintain compliance with regulatory standards.
* Regulatory Standards and Procedures: Oversee the development and upkeep of regulatory standards and procedures in strict accordance with all applicable regulatory regulations, guidance, and specifications. The attention to detail will be vital in upholding the highest industry standards.
The correct candidate for this opportunity will have extensive GMP and GDP knowledge including working closely with a quality management system within the pharmaceutical distribution setting. If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.
STR Limited is acting as an Employment Agency in relation to this vacancy.