Compliance Specialist / Audit And Inspection Lead

Job title: Compliance Specialist / Audit And Inspection Lead

• Location: Csanyikvölgy, Miskolc
• Hiring Manager: Balázs Kepiro
• Job Type: Fixed term, full-time

Main Accountabilities

• Contributing to the development and maintenance of an effective compliance program

• Ensuring all operations comply with relevant regulatory requirements and other international standards

• Providing training and guidance to employees on compliance-related topics

• Maintaining compliance-related documentation, ensuring accuracy and completeness

• Identifying potential compliance risks and contributing to the development of strategies to mitigate them

• Supporting the investigation and reporting of compliance incidents

• Managing CAPA to address compliance incidents and preventing recurrence

• Contributing to continuous improvement initiatives to enhance compliance processes and systems

• Preparing and participating in internal and external audits and regulatory inspections

• Developing and implementing an annual self-inspection plan

• Reviewing the internal audit reports before submission to senior management to ensure accuracy and consistency

• Ensuring an inspection readiness process is in place to manage announced and unannounced inspections

• Leading and managing regulatory inspections and audits

• Identifying near misses during inspections and recommending corrective actions

  ·         Reviewing inspection outcome and contributing to the answers

• Monitoring the implementation of corrective and preventive actions (CAPAs) related to audit and inspection

  Representing the site in the CoP, could be a member of the CoE, and ensuring local communication

Key roles (D,A,I)

·         Support management on compliance topics (A)

·         Review the relevance of remediation action from findings from internal and external audits related to health-related topics (A)

·         Advise on improvements to compliance processes and systems (A)

·         Advise on risk mitigation strategies (A)

·         Advise on corrective actions for compliance incidents (A)

·         Advise on continuous improvement initiatives (A)

Coordinate quality alert and batch recall process with global team (A)

·         Decide on the structure and timing of internal audit plans and schedules, based on risk assessment (D)

·         Advise on corrective actions for identified non-compliance issues (A)

·         Monitor and track actions for near misses in the database (I)

Track and inform relevant stakeholders about the status of CAPA implementation (I)

Expected Experience

·         Experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards

·         Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up

·         5 years of experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up

Expected Technical skills

·         In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)

·         Ability to analyze complex compliance issues, identify root causes, and develop effective solutions

·         Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders

·         Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards

·         Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports

·         Ability to analyze complex data and audit findings to identify compliance issues and recommend corrective actions

·         Meticulous attention to detail to ensure accuracy in audit reports, documentation, and compliance assessments

·         Strong verbal and written communication skills to effectively liaise with regulatory bodies, present findings to senior management, and train staff

·         Proficiency in managing multiple audi