Senior Facilities and Engineering Compliance Associate

Competitive
Permanent
Dublin
18 Sep 2019
BBBH741964

Support the execution of manufacturing/quality systems such as non-conformance's, change controls, utilities validation, procedures, training, and NPI

Senior Facilities and Engineering Compliance Associate: Pharmaceuticals: Dublin

Job Purpose:

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformance's, change controls, utilities validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support engineering operations.

Key Responsibilities:

  • Document Control Expertise: Initiate, revise, and approve engineering procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
  • Non-Conformance and CAPA: Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Accountable for meeting deadlines on all assigned compliance related actions.
  • Safety Incidents and CAPA: Ensure that all safety incidents are critiqued within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing safety incidents, investigation and corrective action closure within established goal. Monitor and communicate incidents trends. Accountable for meeting deadlines on all assigned compliance related actions
  • Utilities Validation: Assist with generation of utilities validation protocols and reports. Assist with the execution of the utilities validation. Support collection and analysis of utilities validation data.
  • Change Control Assist manufacturing change owner on CCRB packages impacting the process. May own change controls
  • Projects and Initiatives: Participate on the assessment or implementation of special projects or initiatives.
  • Metrics: Generate Compliance Metrics for Engineering group. Provide reports on Quality and Safety Compliance.

Education and Experience:

  • B.A. /B.S. in Biology/Life Science/Engineering or the equivalent combination of education and experience.
  • 3- 5 years' related and increasingly complex manufacturing/engineering experience
  • Detailed technical understanding of manufacturing/engineering unit operations.
  • Skilled in performance of GMP production operations
  • Regulatory knowledge and interactions
  • Participate and help lead cross-functional teams
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Organizational, technical writing and presentation skills.
  • Good project management skills.
  • Basic knowledge of control charting

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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