GMP Compliance Audit Manager (职位编号：40685925)社

面议

市辖区本科及以上7年及以上

发布时间：2023-09-06

职位描述

Purpose
Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks.Provide GMP compliance expertise to internal and external customers.Perform tasks and work to achieve company goals and organizational objectives. Key Responsibilities
？ Lead and Participate in audits. Develop audit findings that address individual gaps and system gaps. Can lead all "low risk" and most "high risk" area audits. Can participate on all high risk audits. Report requires little or no input from manager. May be asked to participate in meetings post audit to discuss unresolved issues with Senior Management.
？ Identifies gaps in corporate practices, policies and procedures and prioritizes based on current regulatory environment, guides and regulations. Leads teams to remediate or defend identified risks. Works with customers to develop CAPs and CAs for identified audit findings. Presents information on outcomes to Sr. Management.
？ Author compliance opinions. Needs no guidance from manager on resources I references. Opinion has depth and breadth and requires little or no input from Manager I review team.
？ Identifies gaps in corporate practices, policies and procedures. Leads efforts to remediate gaps. Write and or participate in corporate document development.
？ Participates in response development to regulatory inspection observations.
？ Author responses if assigned. Acts as a SME for PTQE.
？ Participates in FDA Meetings. Acts as a SME for PTQE.
？ Participate as a PTQE representative in team meetings. Is a SME on compliance issues. Independently raises compliance issues with the team. Provides input on issues discussed informing manager of resolution. Communicates issues to manager as necessary.
？ Attends meetings, conferences and workshops benchmarking industry activities
？ Reviews FDA-483 observations, EIRs, audit findings to identify corporate issues.
？ Independently reviews and comments on regulatory agency draft documents.
？ May lead team to formulate Roche positions.
？ Set personal performance goals and provide input to departmental objectives.
？ Establish work priorities to meet targets and timelines.
？ Manage competing priorities and allocate, adjust, and optimize assigned department resources.
？ Serve as the Compliance representative on cross-functional and multi-site teams.
？ Apply advanced theory, technical principles, expert judgment, and cross- functional expertise to independently address a broad range of complex problems.
？ Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
？ Make decisions that impact the goals and objectives of the department.
？ Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
？ Sign documents for activities as authorized and described by Roche policies, procedures and job descriptions.
？ Be accountable for behaviors as described in Roche's Core Competencies.
？ Perform any other tasks as requested by Management to support Quality oversight activities.
？ Local Safety requirement
Comply with all local Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
Observe all local site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
？ Lean Production System
Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviours through the use and application of LPS tools for continuous improvement initiatives.
Qualifications:
？ Expert knowledge of GMPs and compendia.
？ Ability to interpret and relate Quality standards for implementation and review
？ Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
？ Ability to communicate clearly and professionally both in writing and verbally
？ Flexibility in problem solving, providing direction and work hours to meet business objectives
？ Virtually self-supervised. Manages projects and works with management to obtain resourcing.
？ Interacts primarily with co-workers, supervisor, internal and external stakeholders and management. Leads interactions with senior management and internal and external customers to negotiate actions and leads teams.
？ Bachelors/Masters degree or above preferably in a scientific discipline， 10+ years working in a regulated GMP environm**********************

其他要求

招聘人数：1人
职能类别：法务合规经理/主管

公司介绍

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗**、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与**、医疗机构以及非**组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

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