Global Quality Assurance Specialist
il y a 3 jours
We are seeking a highly skilled Global Quality Assurance Specialist to join our team at Eli Lilly and Company. As a key member of our Global Quality Auditing and Compliance division, you will play a critical role in ensuring the quality and compliance of our pharmaceutical development and product commercialization processes.
Key Responsibilities- Conduct internal and external audits to assess compliance with company standards, policies, and regulatory requirements.
- Participate in the risk assessment of GMP operations and contribute to the development of the GQAAC risk-based annual audit plan.
- Escalate any compliance issues and ensure timely reporting of audit findings.
- Develop and maintain a comprehensive knowledge of applicable regulations, technical knowledge, and training to meet the requirements of the role.
- Participate in the preparation and review of standards, policies, procedures, and guidelines that establish quality requirements.
- Contribute to the preparation of organizational metrics and trending of audit findings.
- Provide audit-related advice to GMP operations on the interpretation of corporate and regulatory GMP requirements.
- Establish and maintain relationships with relevant business areas and regulatory authorities.
- Maintain good interpersonal and communication skills with auditees and business areas.
- Complete required training for the roles identified in the assigned Learning Plan.
- Stay up-to-date with current industry trends and regulatory agency interpretation of GMP requirements.
- Seek self-development in GMP areas and share knowledge with other members of the group or company.
- Relevant experience within the relevant GMP area at Lilly or within the pharmaceutical industry.
- Ability to interpret and apply regulations, regulatory guidance, and identify and recommend compliance changes as appropriate.
- Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
- Ability to deliver timely and professional communications with precision and clarity to all levels of the organization.
Bachelor's Degree (or equivalent work experience) in physical or biological sciences, engineering, or other technical area.
This is a remote working role, and suitable candidates will currently be located in Europe and hold a full EU or UK passport. Domestic and international travel is required to fulfill these job responsibilities, and you must be able to travel up to 40%, sometimes at short notice.
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