Maintains a leadership role in providing Quality and Compliance oversight of site operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.
As a Associate Manager Quality Compliance, a typical day might include, but is not limited to, the following :
- Ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities and materials management
- Overseeing site quality systems including but not limited to; Deviations, CAPA, Change Control, Audits (Internal and External) and Customer Complaints
- Being responsible for review and approval of the following types of documents, relating to area functions : Failure investigations, Change control documents, Corrective / preventative action documents, Standard operating procedures
- Approving procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
- Monitoring and trending metrics for site quality systems
- Managing and developing site risk assessment activities and site risk register
- Participating in continuous improvement initiatives
- Participating in regulatory and customer audits
- Collaborating with functional departments to resolve issues and maintain compliance
- Identifying gaps in systems and developing feasible plans for correction
- Training of personnel on quality system processes
To be considered for this position you have BSc / BEng in scientific discipline or related field with 7+ years of relevant work experience in pharmaceutical or related industry.
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