About this role
The Quality Compliance Specialist is responsible to:
- Support the execution of site quality compliance programs to ensure site adherence to AbbVie Policies, and current Good manufacturing practices (cGMP) requirements per regulatory standards.
- Support site quality compliance programs for Internal Audit and External Inspection Management, Regulatory Affairs Submission, Product Complaints, Recall Management, Quality Manual/ Site Master File, Management Review, Quality Metrics, Quality Risk Management, Data Governance and Quality Plan management, as assigned.
Major Responsibilities
Internal Audits and External Inspection Management
- Support in inspection management activities to ensure site inspection readiness for regulatory inspection in Pre-Approval Inspection or GMP surveillance inspection.
- Support internal lead auditor to perform self-inspection as co-auditor
- Support Compliance Partner Program, in assigned site departments, to ensure compliance to the requirements of applicable regulations that pertain to pharmaceutical and biopharmaceutical Manufacturing.
Compliance Systems Management
- Support in activities for Product Complaints, Recall Management, Quality Manual/ Site Master File, Management Review, Quality Metrics, Quality Risk Management, Data Governance and Quality Plan management.
- Support initiatives in collaboration with site functional areas/departments to ensure inspection readiness in operations
Regulatory and Filing Submission Management
- Assist in regulatory submission activities for product filing, and maintenance of HSA Manufacturing Licenses and GMP certification from relevant regulatory agencies, as assigned.
- Assist in maintenance of Site Master File and Quality Manual
Data Governance
- Support and assist in promotion and training Trainer for data integrity and associated procedures (e.g. Data integrity Risk Assessment, Audit Trail Review), as assigned.
Quality Risk Management
- Support and assist in data collection or tracking of Quality Risk Management activities, as assigned
Product Complaint and Recall Management
- Support and assist in mock recall annual exercise including planning and execution of the plan, as assigned
Quality Plan
- Support and assist in data collection or tracking of Quality Plan activities, as assigned.
Education
- Bachelors / Masters in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- A minimum of 2-5 years in a cGMP regulated environment is required.
- A minimum of 2 years of relevant experience in compliance and audit is preferred.
- Specialization in quality / compliance areas such as audit management, product review, customer complaints, management review, quality metrics, quality risk management and data governance in either small molecule API or Biologics manufacturing is preferred.
- Good knowledge of regulatory standards and guidelines (such as ICH, CFR, Eudralex, PIC/S) is preferred.
- Proven problem-solving skills and the ability to adapt to changes is preferred.
- Strong communication skills both verbal and written are required.
- Strong interpersonal skills are preferred.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html