东莞招聘

• Prepare and conduct internal and external audits for Viatris
• Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (GxP and ICH) including assessment of applicability and impact on systems being audited.
• Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management.
• Provide interpretation of complex regulations through research of current corporate and governmental expectations.
• Perform GXP internal and external audits based on a defined audit plan within specific time constraints, including the facilitation of opening and closing audit meetings with all levels of Management, the preparation of  all associated documentation including audit plans and audit reports under strict confidentiality, and track and monitor audit responses and the implementation of corrective actions.
• Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards.
• Author and approve Quality Compliance procedures.
• Serve as a compliance reference regarding GXP Interpretations for all levels of Management.
• Serve as a liaison within the many GXP departments of Mylan Inc. to effectively establish compliant quality systems.
• Plan, schedule, and arrange travel to various sites based upon guidance from Management.
• Requires domestic and international travel (approximately 50% of the time).
• Perform other duties as assigned.

The minimum qualifications for this role are:

• Minimum of a Bachelor's degree (or equivalent) and minimum of 6 years of experience.  However, a combination of experience and/or education will be taken into consideration.
• Must possess a sound knowledge of national, international, and supranational cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being audited. Must be familiar with all other GXP concepts.
• Position functions within a team structure with no direct supervisory requirements.  Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities may include planning, assigning, and directing work
• Ability to read and interpret complex business and/or technical documents.  Ability to write comprehensive reports and detailed business correspondence.  Ability to work with groups of people such as other departments and communicate known concepts.  Ability to present to a group of departments.  Must be proficient in spoken and written English.

• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.  Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

 

晖致（Viatris）是一家全球医疗健康公司。我们志在通过“可及”、“引领”以及“合作”三大途径实践我们的使命——帮助世界各地的人们在生命的每个阶段生活得更加健康。晖致在全球拥有多样化的产品组合，覆盖十多个治疗领域，涉及约1,400个化合物和生物制品，以及45,000名具备丰富专业知识的员工，共同服务全球165个市场。我们在中国约有5,000多名员工，业务覆盖全国300余个城市，已有20多个享誉全球的优质药品在中国上市。基于覆盖广泛治疗领域的产品和前瞻性的疾病管理理念，以及强大的商业能力和先进的数字技术，晖致致力于为中国市场提供以患者为中心的世界品质的药品和健康管理服务，助力健康中国2030宏伟目标的实现。