Quality Assurance Specialist

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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