Quality Remediation Consultants

Job Title: Quality System Specialist

Area: Repackaging (Onsite - 6 Months)

Location: Ohio, USA

Position Type: Full-Time

Job Description:

Our client is a prominent repackaging company serving hospitals and health systems in Ohio. ProQuality Network is seeking a highly skilled Quality System Specialist for an onsite assignment lasting 6 months. The successful candidate will be a key contributor to our commitment to maintaining the highest standards of quality, data integrity, and regulatory compliance in the repackaging processes. This role demands a seasoned professional with expertise in leading Quality Systems, ensuring data integrity, conducting validations, and driving quality remediation initiatives.

Key Responsibilities:

• Provide comprehensive remediation solutions to our client's repackaging operations.
• Lead various workstreams and ensure the successful execution of the remediation processes:

1. Assessment and Analysis:

• Conduct a thorough assessment of the current quality issues within the repackaging processes.
• Analyze existing quality control measures and identify areas requiring remediation.

2. Resource Allocation:

• Assign a team of five experienced professionals with expertise in quality management, process improvement, and regulatory compliance.
• Tailor resources to specific workstreams to maximize efficiency and effectiveness.

3. Project Management Office (PMO)

• Establish a dedicated PMO to oversee and coordinate all aspects of the remediation project.
• Provide centralized project leadership, communication, and reporting to ensure alignment with organizational goals.

4. Workstream Leadership:

• Assign dedicated leaders to individual workstreams, ensuring focused attention on specific aspects of the remediation process.
• Workstreams may include process redesign, training programs, documentation updates, and technology enhancements.

5. Process Redesign:

• Collaborate with key stakeholders to redesign and optimize repackaging processes.
• Implement improvements to enhance efficiency, reduce errors, and meet regulatory standards.

6. Training Programs:

• Develop and implement customized training programs for personnel involved in repackaging operations.
• Ensure that employees are well-versed in the updated processes and quality standards.

7. Documentation Updates:

• Review and update quality documentation, including standard operating procedures (SOPs) and quality manuals.
• Align documentation with industry best practices and regulatory requirements.

8. Technology Enhancements:

Evaluate existing technology used in repackaging processes.

Recommend and implement enhancements or new technology solutions to streamline operations and improve quality control.

Benefits:

Our Quality Remediation Process aims to deliver the following benefits to our Client:

• Improved overall quality control and assurance in repackaging operations.
• Enhanced regulatory compliance and alignment with industry standards.
• Increased operational efficiency through optimized processes and technology enhancements.
• Empowered personnel with targeted training programs.
• Comprehensive project oversight and coordination through the dedicated PMO.

Skills and Qualifications:

• Demonstrated leadership experience in Quality Systems within a pharmaceutical or repackaging environment.
• Expertise in ensuring data integrity and implementing measures to uphold data quality.
• In-depth knowledge of validation processes, including equipment, process, and computer system validations.
• Proven track record in quality remediation initiatives and driving corrective and preventive actions.
• Strong understanding of investigations, risk assessment, and CAPA management.
• Ability to collaborate effectively with cross-functional teams and stakeholders.
• Excellent analytical and problem-solving skills with a keen attention to detail.

Education and Experience:

• Bachelor's degree in a scientific or related field.
• Minimum of 7 years of relevant experience in a quality-focused role within the pharmaceutical or repackaging industry.
• Knowledge of relevant regulatory standards and guidelines.

We are committed to collaborating closely with your team to ensure a successful and seamless implementation of the Quality Remediation Process, addressing, and resolving quality challenges to elevate your repackaging operations to the highest standards.

Join ProQuality Network in our commitment to providing high-quality repackaging solutions to healthcare institutions. If you are a seasoned Quality System Specialist with a passion for ensuring data integrity and driving quality excellence, we invite you to apply for this exciting opportunity. Your expertise will contribute to the safety and well-being of patients served by hospitals and health systems.