The Compliance Engineer will be part of a manufacturing functional team. The team plays a leading role as change agents in supporting the site towards the zero defects goal. The team will focus on discrepancy (unplanned events) management, identify and implement remediation and proactive continuous improvement across the organization representing all functions. The position requires proficiency in facilitation of investigations, analytical thinking toward identifying root cause, teamwork, collaboration to identify and implement solutions, technical writing capabilities to write clear and concise quality records. The position requires skill and knowledge in Technical Writing, Quality Systems, RCA Methodologies, Risk Management, Continuous Improvement Methodologies, Project Management and presentation to Health Authorities/ audits.
Responsibilities:
● Manage the investigation Unplanned Events (iUPE) end-to-end process as Owner in accordance with procedures, performance measures, and standard lead times.
● Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
● Effectively facilitate cross-functional discussions associated with investigation’s cause, remediation and impact analysis.
● Collaborate with cross-functional groups to identify, design and implement process and system improvements and initiatives.
● Lead trending analysis to identify systemic issues and facilitate resolution to prevent trends/ issues.
● Drive continuous improvement to develop and implement initiatives in cross-functional collaboration to reduce defects in identified problem areas.
● Manage the remediation as Owner (if necessary), working collaboratively across several functions to achieve timely closure.
● Manage assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
● Support and participate in site inspection readiness initiatives, audits, and regulatory inspections.
● Manage work and competing priorities to achieve department objectives and company goals.
● Own the development of personal performance goals and departmental objectives.
● Identify and solve the problems proactively.
● Collaborate with necessary stakeholders to establish processes to meet targets and timelines for UPE management and continuous improvement initiatives.
About You:
● At least a degree in a relevant science/engineering discipline.
● At least 5-7 years of relevant experience in the pharmaceutical industry.
● Exhibits good knowledge of international cGMP and compliance requirements.
● Proficiency of the technical process and workflow of discrepancy/ Unplanned Events Process.
● Strong technical writing skills.
● Display a good level of problem solving ability and provide suggestion/alternative solutions on complex issues resolution.
● Displays strong interpersonal, exceptional teamwork and collaboration skills.
● Highly motivated, well organized and able to develop alternate solutions to issues.
● Ability to communicate clearly and professionally in both writing and verbally.
● Experience with mammalian/bacterial biopharmaceutical production strongly preferred.
