Compliance Specialist – Technical Operations
Industry : Pharmaceutical
Department: Technical Operations (Automation, Engineering & Facilities)
The Compliance Specialist, Technical Operations is a member of the Technical Operations Team (Automation, Engineering & Facilities) and is responsible for operations support and compliance related activities for the manufacture of medicinal products.
Essential Duties and Responsibilities include, but are not limited to the following:
• Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
• Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement.
• Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
• Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
• Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering documentation, etc. to assess for compliance with established quality standards, policies and procedures.
• Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established quality standards, policies and procedures.
• Provide tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.
• Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required.
• Continuous Improvement Implementation.
• May require supervisory responsibilities.
Role knowledge, skills and abilities:
• Knowledge of drug product manufacturing equipment, instrumentation and supporting utilities.
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
• Strong interpersonal, written, presentation, communication and investiagtion skills with the ability to engage with a diverse range of individuals across all levels of the organization.
• Shows resiliency and flexibility in the face of challenges and adversarial situations.
• Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
• Ability to work on own initiative, without direct supervision from management.
Education & Experience:
• Specialist; minimum of BA/BS in Engineering/Science discipline with 2+ years experience working in a cGMP environment.