Quality Compliance Specialist II

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.

Employment type
Full-time

Work arrangement
No