Regulatory Compliance Engineer

2 weeks ago

Shannon Co Clare, Ireland Cregg Recruitment Full time

Regulatory Compliance Engineer - Co. Clare Company Information: Our client is a leading Biopharmaceutical company in Co. Clare.The company is committed to delivering innovative and quality productsthat save and improve lives around the world. Known for its industry-leading standards and focus on innovation,offeringa dynamic environment for professional growth and development. This role offers a very competitivesalary and full extensive company benefits package. Role Profile: As a Regulatory Compliance Engineeryou will be responsible for ensuringthat all engineering documents, projects, products, and processes adhere to relevant local, national, and international regulations, standards, and guidelines. This includes safety, environmental, quality, and industry-specific standards. Responsibilities: Documentation: Maintain thorough and accurate records of engineering activities, including test reports, certifications, and audit findings. Prepare and review engineering documentation related to product quality and compliance including GMP standard operating procedures. This documentation helps demonstrate adherence to standards and regulations. Regulatory Compliance: Ensure that all engineering documents, projects, products, and processes adhere to relevant local, national, and international regulations, standards, and guidelines. This includes safety, environmental, quality, and industry-specific standards. Risk Assessment: Identify potential risks and compliance issues in engineering projects and work proactively to address them. This may involve conducting risk assessments and implementing corrective actions. Audits and Inspections: Prepare for and participate in internal and external audits, ensuring that the engineering work is in compliance with the applicable standards. Address non-compliance issues and track corrective actions. Quality Control: Develop and implement quality control processes to monitor engineering activities, products, and systems to meet specified requirements. Conduct investigations and write reports for issues/deviations within the dept. Ensure CAPA actions for the dept are completed in a timely manner Collaboration: Work closely with the engineering teams, and other departments to ensure compliance with established standards. Participate in daily and weekly departmental and interdepartmental meetings and value streams. Testing and Validation: Plan and conduct tests and validation processes to verify that engineering designs and products meet the required standards and regulations. Continuous Improvement: Stay up-to-date with changes in regulations and standards and proactively implement improvements in engineering processes and products to maintain compliance. Reporting: Provide regular reports to management and relevant stakeholders on compliance status, audit findings, and areas that may need improvement. Job Competencies: This role has No Direct reports Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken. Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state. Requirements: Bachelor's or higher degree in engineering or a related field. Knowledge of relevant regulatory and industry-specific standards and requirements. Strong analytical and problem-solving skills. Attention to detail and a strong commitment to quality. Excellent communication and interpersonal skills. Project management and organizational abilities. Familiarity with Computerised maintenance management systems is a plus (Maximo). Familiarity with QMS - quality management systems - (Mastercontrol) is a plus. Experience in a similar role is preferred. If youre interested in this opportunity and would like to discuss, please contact Gary at or call Skills: Quality Engineer CAPA GMP Complaints RCA problem solving QMS Benefits: Paid Holidays Canteen Parking Share options Pension Bonus Vouchers

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