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Sr. Principal Associate-GQAAC
vor 4 Monaten
We’re looking for people who are determined to make life better for people around the world.
The Quality Auditor is part of the Lilly Global Quality Auditing and Compliance (GQAAC) division and assures quality assurance through the execution of internal and external audits in support of pharmaceutical development, product commercialization, for Lilly. Through auditing, the Global Quality Auditor assures that GMP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations, applicable guidelines and industry standards.
GQAAC operates as a valued business partner by taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance. The Quality Auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight.
Key Objectives/Deliverables:
The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:
Auditing:
·Scheduling, preparing, conducting and reporting audits and assessments of GMP operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.
·Participate in or lead the risk assessment of GMP operations in support of generating the GQAAC risk-based annual audit plan.
·Appropriately escalate any compliance issues.
·Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
Global Quality – Business Related Responsibilities:
·Participate in or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.
·Participate in or lead the preparation of organizational metrics and trending of audit findings, when required.
·Provide audit-related advice to GMP operations on the interpretation of corporate and regulatory GMP requirements (standards/policies/procedures) related to quality management, when required.
·Establish and maintain relationships with relevant business areas and regulatory authorities, including support for regulatory inspections, when required.
·Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.
Personnel Development:
·Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
·Complete required training for the roles identified in the assigned Learning Plan
·Be continually aware of current industry trends and regulatory agency interpretation of GMP requirements.
·Seek self-development in GMP areas (e.g. attend training courses, conferences or association meetings) and share such information and knowledge with other members of the group or company to increase internal intelligence.
·Participate or lead divisional improvement efforts,
·Support training and qualification of other auditors.
Minimum Requirements:
·Relevant experience(s) within the relevant GMP area at Lilly or within the pharmaceutical industry
Additional Preferences:
·Be considered a subject matter expert (SME) in one or more relevant areas of pharmaceutical technology – such as
oBiotechnology
oAseptic manufacturing
oNew Modalities such as Gene therapy, mRNA, Cell or Tissue therapy,
oPharmaceutical engineering technology
·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 (oral and written) with precision and clarity to all levels of the organization.
·Experience working on a global team and sharing knowledge.
·Experience with computers and entering data into databases.
·Good analytical/problem-solving skills.
·Experience working with Third Party Organizations.
·Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
·Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
·Work independently as well as collaboratively within a global team environment.
·Establish and maintain effective working relationships at all levels internal and external to Lilly.
·Ability to think on your feet and be pragmatic in decision making.
Education Requirements:
Bachelor’s Degree (or equivalent work experience) in physical or biological sciences, engineering or other technical area.
Other Information:
Other Information:
This is a remote working role. Suitable candidates will currently be located in Europe and hold a full EU or UK passport. Relocation benefits will NOT be offered for this role. You must be located within reasonable commuting distance of a major airport. Domestic and international travel is required to fulfil these job responsibilities. Must be able to travel up to 40%, sometimes at short notice.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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