Position Overview:
As a Quality Executive in Pharma Packaging, your role is crucial in ensuring the highest quality standards are maintained throughout the pharmaceutical packaging process. You will be responsible for monitoring, evaluating, and implementing quality control measures to guarantee that pharmaceutical products are packaged in compliance with industry regulations, company standards, and safety protocols.
Key Responsibilities:
1) Quality Control Oversight:
- Conduct thorough inspections of packaging materials, equipment, and processes to identify defects, deviations, and potential quality issues.
- Collaborate with cross-functional teams to establish and maintain quality control procedures, ensuring they align with current regulations and company policies.
- Perform regular audits of packaging lines to verify compliance with Good Manufacturing Practices (GMP) and other relevant quality standards.
2) Documentation and Reporting:
- Maintain accurate and up-to-date records of quality control tests, inspections, and findings.
- Prepare detailed reports on quality performance, highlighting any deviations or areas of concern.
- Communicate quality-related data and trends to relevant stakeholders, including senior management, to facilitate informed decision-making.
3) Root Cause Analysis and Issue Resolution:
- Investigate root causes of quality issues and non-conformities, utilizing problem-solving methodologies like root cause analysis (RCA) and corrective action preventive action (CAPA).
- Collaborate with production, engineering, and quality assurance teams to develop and implement corrective and preventive measures to address identified issues.
4) Process Improvement:
- Continuously identify opportunities for process improvements to enhance packaging efficiency and reduce the likelihood of quality-related incidents.
- Recommend and implement best practices to optimize packaging procedures and minimize errors.
5) Regulatory Compliance:
- Stay current with relevant regulatory guidelines and industry standards related to pharmaceutical packaging.
- Ensure all packaging activities adhere to regulatory requirements, including FDA regulations and other applicable guidelines.
6) Training and Development:
- Provide training to packaging operators and other relevant staff on quality control procedures, standards, and best practices.
- Foster a culture of quality awareness and continuous improvement within the packaging department.
7) Equipment Maintenance:
- Collaborate with maintenance teams to ensure that packaging equipment is properly maintained and calibrated to prevent breakdowns and ensure consistent quality output.
Qualifications and Requirements:
- Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
- Prior experience in quality control or assurance within the pharmaceutical packaging industry is preferred.
- Familiarity with Good Manufacturing Practices (GMP) and other relevant quality standards.
- Strong attention to detail and analytical skills.
- Excellent communication skills to interact with cross-functional teams and convey quality-related information effectively.
- Proficiency in using quality control tools and software for data analysis and reporting.
- Knowledge of regulatory requirements and guidelines specific to pharmaceutical packaging.
- Problem-solving skills to identify root causes of quality issues and implement effective solutions.
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