Activités Industrielles
Là où les miracles
de la science
deviennent une réalité pour les patients

Main Accountabilities:

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements.

• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations.

• Conducting regular audits of production processes to identify and address potential quality issues.

• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor.

• Managing and resolving quality-related issues in a timely and effective manner.

• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed.

• Leading root cause analysis investigations for quality incidents and implementing preventive measures.

• Participating in internal and external audits and regulatory inspections providing support and documentation.

• Developing and implementing risk management strategies to mitigate potential quality issues.

• Fostering a culture of quality and continuous improvement across the organization.

Key Involvement in Decision Making Process

Key Roles (D,A,I):

• Request corrections when GMP rules are not respected (D)

• Prioritize quality and compliance objectives (A)

• Proactively implement remediation action from findings from internal and external audits related to quality issues (D)

• Request quality improvement initiatives and strategies (D)

• Identify discrepancies and corrective/preventive actions that need to be taken (D)

• Escalate to upper management any failure in GMP execution on shopfloor (I)

• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)

• Advise on how to present a topic and answer specific questions (A)

• Advise on risk management strategies and plans (A)

• Advise on initiatives to promote a quality-focused culture (A)

Requirements/Qualifications

Expected Experience

• 1-2 years experience in quality assurance within the pharmaceutical industry

• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

Expected Technical skills

• Ability to analyze complex data and identify trends, issues, and solutions

• High level of accuracy and attention to detail in all quality assurance activities

• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies

• Proficiency in identifying problems and implementing effective corrective actions

• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards

Language

• Local language and English

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