Quality Assurance Specialist

Job Description:

Responsibilities

• 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.

Qualification & Experience

• 5-7 years of experience in quality assurance within the pharmaceutical industry.
• Bpharm/ Mpharm. 
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles