验证主管岗位职责汇编(2篇)

岗位职责是什么

验证主管是企业质量管理体系中的关键角色，负责确保产品或服务的质量符合既定标准和法规要求，通过严谨的验证流程确保公司的运营效率和客户满意度。

岗位职责要求

1. 具备深厚的行业知识和实践经验，熟悉相关领域的质量标准和法规。

2. 精通验证方法和流程，能设计并实施有效的验证方案。

3. 具备出色的组织协调能力，能有效管理验证团队，确保任务按时完成。

4. 严谨细致，对数据敏感，能准确分析验证结果。

5. 良好的沟通技巧，能与各部门有效协作，解决质量问题。

6. 强烈的责任心和风险意识，能在问题出现时迅速采取应对措施。

岗位职责描述

验证主管在日常工作中，需要监控和评估生产或服务过程，确保其符合预设的验证标准。他们需要制定和更新验证计划，确保其适应不断变化的业务环境和法规要求。此外，他们还需要对新引入的技术、设备或流程进行严格验证，以保证其安全性和有效性。

有哪些内容

1. 验证计划与执行：制定全面的验证计划，包括验证范围、目标、方法和时间表，并监督执行，确保计划的顺利完成。

2. 团队管理：招募、培训和指导验证团队成员，提升团队的整体能力和效率。

3. 文件管理：维护验证记录，确保所有数据的准确性和完整性，以便于审计和追踪。

4. 风险评估：识别潜在的质量风险，制定预防和纠正措施，防止问题的发生。

5. 内外部沟通：与内部各部门、供应商及监管机构保持良好沟通，确保验证活动符合各方期望。

6. 不断改进：分析验证结果，识别改进点，推动质量管理体系的持续优化。

7. 法规合规：跟踪最新的法规动态，确保公司的验证活动始终符合法律法规要求。

验证主管的角色不仅关乎产品质量，更关乎企业的声誉和客户信任。他们通过专业的验证工作，为企业稳定运营提供坚实保障，助力企业在竞争激烈的市场中赢得优势。

验证主管岗位职责范文

第1篇 qc验证主管岗位职责

qc validation/qualification supervisor仪器验证主管 诺化仕(无锡)制药有限公司 诺化仕(无锡)制药有限公司,诺化仕,诺化仕 job summary:

•ensure the maintenance and qualification of the analytical and metrological equipment of the novacyl quality control laboratory;

•support non-routine analytic activities such as analytical validation, analytical transfers and method troubleshooting;

•manage the analysts in charge of qualification and validation activities (resources from the hplc and physical chemistry laboratory seconded to the qualification/validation projects).

mains missions :

•maintenance/qualification of laboratory equipment ;

•management of analytical transfer and validations.

mission 1: maintenance

? organizes the preventive maintenance (internal or e_ternal) and the periodic verifications (internal or e_ternal) of the equipment of the laboratory (planning / follow-up of the supplier) in the respect of the deadlines and costs

? organizes the curative maintenance of laboratory equipment during breakdowns (internal or e_ternal) (planning / monitoring of service providers)

? manages stocks of spare parts needed for first-level maintenance

? represents the maintenance pole during audits and inspections by the authorities

? supports laboratory technicians in case of equipment problems

? organizes calibration/verification of standards dedicated to equipment verification by e_ternal agencies

mission 2: qualification laboratory equipment

? write the equipment qualification documentation for the laboratory (urs, protocols ....)

? organize qualification by suppliers

? conduct and / or organize additional tests not performed by suppliers (internal or outsourced)

? write the equipment usage documentation (operating modes, logbooks ...)

? presents qualification records during audits and inspections by the authorities

? ensures the training of technicians in the use of equipment

? organizes equipment supplier qualification

? participates in the choice of laboratory equipment and software

mission 3: coordination of analytical transfer, validations and troubleshooting activities

? supports the technicians in case of analytical problem, technical oos, technical question ? write the study protocols/report for the laboratory off stream activities (analytical validation, transfer ...) ? organise with the laboratory staff the studies for off stream activities (analytical validation, transfer ...)

? participates in the creation / modification of the working documentation (analytical methods, work instructions…

mission 4: laboratory life

? participates to various meetings related to the operation of the service (daily, monthly ...) ? leads actions to improve the operation of the maintenance center and the laboratory. ? defines with the manager the investment strategy for laboratory equipment ? is the system administrator of the labs si

required skills:

1. bachelor degree in relevant;

2. with 5-10 years professional e_perience in a quality control laboratory in a gmp environment;

3. spoken english is a plus;

4. good knowledge of the standards applicable to the laboratory (pharmacopoeia, .ich...);

5. good understanding of equipment and analytical laboratory techniques (titration, gc, hplc, spectroscopy, karl fischer, ....);

6. knowledge of software related to laboratory equipment.

第2篇 验证主管岗位职责

验证主管 安礼特(上海)医药科技有限公司 安礼特(上海)医药科技有限公司,安礼特 五、验证主管1-2人

岗位职责

1、参与生产系统验证,计算机化系统验证项目实施

2、制定验证总计划/风险评估/设计文件/验证文件/验证报告/追溯矩阵文件

3、参与验证过程中的偏差、变更处理。

岗位要求:

1、具有药学相关专业本科以上学历;

2、有参与建立验证体系的经验。

3、制定过gmp验证总计划和验证实施计划。

4、有固体制剂设备、公用系统确认经验

5、熟悉验证过的主要设备原理。

6、懂计算机化系统验证者优先

7、具有基础的制药装备自动化、应用软件基础知识。