Position Overview:

The Quality Assurance Executive in the pharmaceutical industry is responsible for ensuring compliance with regulatory standards and internal quality processes to maintain the highest level of product quality and safety. They play a critical role in overseeing quality systems, implementing quality control measures, and continuously improving processes to meet industry standards and customer expectations.

Key Responsibilities:

Compliance Management:

• Ensure adherence to all relevant regulations, guidelines, and standards set by regulatory authorities and internal quality management systems.
• Review and update standard operating procedures (SOPs) to align with changing regulations and best practices.

Documentation and Records Management:

• Maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation.
• Ensure accurate and timely completion of all quality-related documentation.

Product Quality Control:

• Implement and monitor quality control measures throughout the product lifecycle, from raw materials sourcing to finished product release.
• Conduct regular audits and inspections to assess compliance with established quality standards.

Non-Conformance and Corrective Action:

• Investigate product non-conformances, deviations, and customer complaints to identify root causes and implement appropriate corrective and preventive actions (CAPAs).
• Track and monitor the effectiveness of CAPAs to prevent recurrence.

Training and Development:

• Provide training to employees on quality standards, procedures, and regulatory requirements.
• Foster a culture of quality and continuous improvement within the organization.

Supplier Quality Management:

• Evaluate and approve suppliers through audits and quality agreements to ensure the quality of incoming materials.
• Collaborate with suppliers to address quality issues and drive improvement initiatives.

Validation and Qualification:

• Oversee validation activities for processes, equipment, and systems to ensure they meet the necessary quality standards.
• Support qualification efforts for new equipment and facilities.

Risk Assessment and Management:

• Conduct risk assessments related to product quality, compliance, and regulatory matters.
• Develop risk mitigation strategies and ensure their implementation.

Continuous Improvement:

• Analyze quality data and metrics to identify trends and areas for improvement.
• Propose and lead initiatives to enhance quality systems and processes.

Requirements:

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field.
• Proven experience in quality assurance within the pharmaceutical industry, with a solid understanding of regulatory requirements.
• Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
• Strong analytical and problem-solving skills with an attention to detail.
• Excellent communication and interpersonal skills to collaborate with cross-functional teams.
• Ability to work in a fast-paced environment and prioritize tasks effectively.
• Familiarity with quality management software and tools is an advantage.