Compliance Specialist Role Overview
We are seeking a Compliance Specialist to join our team in Carlow. This is an excellent opportunity for individuals looking to work with a leading multinational pharmaceutical organization.
The Compliance Specialist will provide compliance support for the SCM/Warehouse/Weigh and Dispense area, ensuring processes and end products comply with corporate and regulatory requirements.
Key Responsibilities:
1. Work as directed by the Warehouse & Weigh and Dispense Area Manager(s) according to Company safety policies and cGMP.
2. Required to drive compliance with policies, procedures, and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
3. Provide support for the SCM/Warehouse/Weigh and Dispense with respect to the following:
* Support the updating of Standard Operating Procedures, Shipping & Receipt Documents, protocols, and associated reports and any other documentation/administration of these documents in direct support to the SCM/Warehouse/Weigh and Dispense.
* Review of eLogs
* Archiving/retrieval of the SCM/Warehouse/Weigh and Dispense documentation.
* Maintaining and controlling the SCM/Warehouse/Weigh and Dispense documentation areas.
* Acts as compliance point of contact for all SCM/Warehouse/Weigh and Dispense documentation topics.
* Assist in the review of SCM/Warehouse/Weigh and Dispense operational procedures, training materials, and procedures for various systems.
* Support documentation in support of investigations, non-conformances, protocols, reports, and change controls.
* Assist in the review of data for periodic reviews as required.
* Drive continuous improvement for all aspects of documentation control/archival.
* Contribute to the achievements of department productivity and quality goals.
* Provide support with audit/inspection requirements to ensure department compliance/readiness.
* Liaise with site QA Document Control group.
* Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections.
Requirements:
* Bachelor's Degree with 3+ years' experience in Pharma and Compliance
* 3-5 years' experience in a quality role (QC/QA), ideally in a pharmaceutical manufacturing environment.
* Experienced with Warehousing Documentation practices