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 audits and inspections simultaneously, including planning, scheduling, and coordinating with various departments

In-depth understanding of pharmaceutical regulations and standards, including Good Manufacturing Practices (GMP) and other relevant guidelines

Language

Fluent in Hungarian and English (written and spoken)

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Why choose us?

· Join a leading pharmaceutical company and contribute to improving health outcomes worldwide.

· Be part of a company at the forefront of medical research and breakthrough therapies.

· Thrive in an environment that values diversity of thought and background.

· Work closely with global and local teams, gaining exposure to various aspects of the pharmaceutical business.

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