Overview
Compliance Specialist RK21961 — Contract – 11 months, Carlow. We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Responsibilities
* Provide compliance support for the SCM/Warehouse/Weigh and Dispense with respect to Standard Operating Procedures, receipt documents, shipping documents, protocols/reports to ensure processes and end products comply with corporate and regulatory requirements to facilitate material handling.
* 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 updating 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 eLogs; archiving/retrieval of the SCM/Warehouse/Weigh and Dispense documentation; maintaining and controlling the documentation areas.
* Act 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.
Experience and Education
* 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.
* Experience with Warehousing Documentation practices.
How to apply
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.
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