Pharmaceutical Compliance Professional
The pharmaceutical industry is a dynamic and challenging field, offering numerous opportunities for professionals who are passionate about ensuring compliance with regulatory requirements. As a Compliance Specialist, you will play a critical role in maintaining the integrity of our operations and upholding the highest standards of quality.
This is an exciting opportunity to join our organization based in Carlow. You will be responsible for providing compliance support for the SCM/Warehouse/Weigh and Dispense, ensuring that all processes and end products comply with corporate and regulatory requirements.
* Key Responsibilities:
* Work as directed by the Warehouse & Weigh and Dispense Area Manager(s) according to Company safety policies and cGMP.
* 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.
* Provide support for the SCM/Warehouse/Weigh and Dispense with respect to the following:
o 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.
o Review of eLogs.
o Archiving/retrieval of the SCM/Warehouse/Weigh and Dispense documentation.
o 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.
* Participate in internal and external audits and inspections.
* Participate in SCM/Warehouse/Weigh and Dispense Tier daily meetings and ensure effective communication of relevant information.
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.