Compliance Specialist

Compliance Specialist

Reference: RK21961
Contract: 11 months
Location: 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:
Responsible for providing 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.

Duties:

- Work as directed by the Warehouse & Weigh and Dispense Area Manager(s) according to Company safety policies and cGMP. 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.
- 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.
- 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.
- Experienced with Warehousing Documentation practices.

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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