GMP Quality assurance analyst
External Job description
GMP Quality Assurance Analyst
Primary Location: Mexico
QIVIA is looking for your talent as a Quiality Analist Mainly responsible for the Product Quality Complaint (PQC) processes, including supply site liaising, case escalation resolution in compliance to applicable process and regulatory requirements. Supports process development, planning, management and execution of initiatives, identifying and raising insights, risk management and mitigation, and contributing to stakeholders training.
- Conducts activities and interactions consistent with organizational values and behaviors and in compliance with the Code of Conduct and supporting policies and standards relevant to the role. Completes all required training on the Code of Conduct and supporting policies and standards within established timeframes. Reports potential issues of non-compliance.
- Conducts a wide range of quality assurance activities of multifaceted scope and complexity on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines.
- Performs the tasks of PQC process to ensure consistent, clear, effective, and timely identification and communication of all PQCs to the appropriate investigation supply sites.
- Understands and supports the PQC related Global and Local regulations as well as processes of external customers.
- Support cross-functional communication by developing and maintaining appropriate and effective liaison relationships with functional areas and clients as required.
- Support document revision to ensure remains up-to-date with consistent, comprehensive and accurate content, and in alignment with Department and Clients policies, especially regarding PQCs.
- Responds to supply site inquiries regarding PQCs and follows up on supply site inquiries with customers as needed.
- Handles Drug Quality Reporting System PQC reports from the Regulatory Authorities, and third-party complaints, and enters them into QA and related systems
- Remains current with evolving regulatory compliance and quality practices related to PQCs
- Supports the continuous processes and performance assessment, customer trends and issues, and program issues and risks. Champions the needs of customers by proactively contributing to the creation and implementation of improvements to processes and systems, and to mitigation of risk.
- Demonstrates the ability to present information to both internal and external stakeholders.
- Alerts project leaders of any suspected potential deficiencies in quality and compliance standards related to PQCs and works with the appropriate stakeholders to support alignment and implementation of corrective and preventative actions.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Requires knowledge and understanding of global Good Manufacturing Practices (GMP) regulatory requirements and industry best practices and an understanding of the principles of GMP quality management, typically obtained through experience.
Typically requires 2 years of experience in pharmaceutical industry within Good Manufacturing Practices (GMP) quality assurance.
Bachelor's Degree: Science / technical (e.g.: Pharmacy, Biology, Chemistry or Engineering) or an equivalent pharmaceutical industry quality assurance background.
Specific experience in GMP at Manufacturing Site or FDA Inspections is desirable.
Strong analytical skills and the ability to organize work in a logical, through and succinct manner. Excellent problem-solving skills.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above information on this description has been designed to indicate the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job. While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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