Compliance Specialist, Warehouse (11M, Carlow)

COMPLIANCE SPECIALIST to provide support for the SCM / Warehouse / Weigh & Dispense required by CareerWise Recruitment for our Life Sciences client in Carlow. Initial 11 month contract on offer.

The COMPLIANCE SPECIALIST provides support 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. Ensures SCM/Warehouse/Weigh and Dispense documentation practices are compliant with site specific and regulatory requirements.

THE ROLE:

• Work as directed by the Warehouse & Weigh and Dispense Area Manager(s) according to Company safety policies and cGMP. Required to drive compliance with Merck Global 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.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current 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.
• Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections.

REQUIREMENTS:

• 3-5 years’ experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environment.
• Bachelor’s Degree with 3+ years’ experience in Pharma and Compliance OR Leaving Cert with 8+ years’ experience in Pharma and Compliance.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.