Ensures cGMP and procedural compliance for the Technical Operations - (Automation, Engineering & Facilities Maintenance)
Summary: Ensures cGMP and procedural compliance for the Technical Operations - (Automation, Engineering & Facilities Maintenance).
Essential Duties and Responsibilities include, but are not limited to, the following:
- 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.
- Initiation, coordination, root cause analysis and authoring of Technical deviation investigations on the quality management system for NOEs (low impact deviations), EOEs (medium to high impact deviations) and DNFs (high impact 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.
- 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.
- Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement.
- 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.
- Participate in audit activities, prepare and implement responses and corrective actions and obtain results for actions for all Technical Operations quality and regulatory audits.
- Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required.
Education and Experience:
- Primary degree in Science/Engineering discipline
- Minimum of 3+ years experience working in a cGMP environment
- Excellent written, presentation, communication and investigation skills with the ability to engage with a diverse range of individuals across all levels of the organization.
- Ability to work on own initiative, without direct supervision from management
- Proficient in MS Office (Word, Excel, Outlook, Access and Powerpoint)
- Knowledge of Electronic Data Management Systems is an advantage
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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