This role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Sr Quality Compliance Specialist a typical day may include:
- Responsible for ensuring compliance with all aspects of Quality inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management. Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
- Collaborates with cross functional teams to resolve issues, complete investigations and maintain compliance.
- Responsible for QA review and approval of the following types of documents: – Failure investigations – Corrective and preventative actions (CAPA)
- Standard operating procedures (SOP’s)- GxP documents – Change control documents Lead & support investigation root cause and resolution ensuring appropriate CAPA actions implemented to prevent recurrence where relevant.
- Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
- Provision of monitoring and trending metrics associated with site quality systems.
- Actively participate in continuous improvement ideas, initiation, and implementation.
- Participation in internal, regulatory and customer audits.
- May train personnel on quality system processes.
- May supervise team members.
- Perform additional duties as requested.
- To be considered for this position you must hold a BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry.
- Relevant experience may be substituted for education requirement. Experience with determining root cause and working knowledge of root cause analysis tools requirements