Responsibilities:
工作职责
• Responsible for Site Quality operations at Cipla China JV Qidong.
• 负责西普拉中国合资企业启东的现场质量操作。
• Responsible for establishing Pharmaceutical Quality system at Cipla China JV Qidong.
• 负责建立西普拉中国合资启东的药品质量体系。
• Releasing or rejecting of all Raw materials, packing materials, In process and Finished products at Cipla China JV Qidong.
• 放行或拒收西普拉中国合资启东所有原材料、包装材料、在制品和成品。
• Ensure that the materials tested and released (Raw/Packing/in process/FP) conform to approved specifications and comply with the requirements of the relevant pharmacopoeia, relevant regulations and quality standards.
• 确保被测试和放行的材料(原料/包装/过程/成品)符合批准的规格符合相关药典、相关法规和质量标准的要求。
• Ensure that the GMP license are acquired, maintained and renewed as per the regulations/requirement.
• 确保GMP许可证的获取、维护和更新符合法规要求。
• Establish and maintain Quality systems as per the CIPLA Global Policy and as per the requirements and regulations of the respective countries for which the products are intended and also as per the regional regulatory requirements.
• 根据西普拉的全球政策、产品所针对的国家的要求和法规以及区域法规要求，建立和维护质量体系。
• Ensure that the drugs are manufactured, tested and stored as per the defined Operating procedures and Guidelines.
• 确保药品按照规定的操作程序和指南生产、测试和储存。
• Ensure that all Qualifications and Validations are carried out as per the approved Schedule and all the protocols and reports are reviewed and approved.
• 确保所有资质和验证都按照批准的进度表进行，所有方案和报告都经过审查和批准。
• Review and approve of change controls, deviations, CAPA and CAPA effectiveness checks.
• 审核和批准变更控制、偏差、CAPA和CAPA有效性检查。
• Participate in all internal and external audits and ensure that the site is ready for inspection at any time.
• 参与所有内部和外部审计，确保现场随时准备接受检查。
• Ensure that the compliance is provided for all the internal and external audit on time.
• 确保按时完成所有内部和外部审计。
• Ensure that all the critical suppliers are qualified and approved, Ensure QTA in place for all critical outsourcing GMP activities.
• 确保所有关键供应商的合格和批准，确保所有关键外包GMP活动的质量协议到位。
• Ensure that Quality Risk management is designed, followed and reviewed as per the laid down procedures.
• 确保按照制定的程序设计、遵循和审核质量风险管理。
• To ensure approved Specifications are in place for all Raw materials, packing materials,
work-in-process and Finished products handled at the site.
• 确保在现场处理的所有原材料、包装材料、在制品和成品的批准质量标准都已到位。
• To ensure that QMS elements such as change control, deviation, CAPA, OOS, OOT, market complaints are closed as per the timelines defined in the SOP.
• 确保QMS要素如变更控制、偏差、CAPA、OOS、OOT、市场投诉等按照SOP中定义的时间线完成。
• Ensure that the Product Quality review are carried out as per the approved procedure.
• 确保按照批准的程序进行产品质量审查。
• Ensure that the process and cleaning employed at the site are validated.
• 确保现场使用的工艺和清洁方法经过验证。
• To approve the procedures, protocols, summary reports, specifications, study reports, hold time reports and other GMP documents executed at the site.
• 批准在现场执行的程序、方案、总结报告、质量标准、研究报告、保存时限报告和其他GMP文件。
• To ensure that the management review meetings are carried out as per the defined frequency.
• 确保管理评审会议按照规定的频率进行。
• Ensure the Sterility assurance for the sterile injectables manufactured at the site.
• 确保现场生产的无菌注射剂的无菌保证。
• Ensure that the drugs are manufactured and released as per the requirements of applicable GMP standards.
• 确保药品按照适用的GMP标准的要求生产和放行。
• Ensured that the Raw materials, packing materials are sourced from the approved vendors and are qualified as per the Cipla vendor qualification policy/procedures throughout the cycle.
• 确保原材料和包装材料均来自经批准的供应商，并在整个生产周期中按照Cipla供应商资格政策/程序进行合格。
• To work closely with cross functional team to ensure and maintain the GMP standards at the site.
• 与跨职能团队密切合作，确保和维护现场的GMP标准。
• To ensure that the stability of the products is carried out as per the approved schedule.
• 确保产品的稳定性按照批准的时间表进行。
• To ensure that the Environmental monitoring are carried out at the site as per the approved frequency.
• 确保按照批准的频率在现场进行环境监测。
• To ensure that the calibration of instruments and equipment are carried out as per the approved frequency.
• 确保仪器和设备的校准按照批准的频率进行。
• To ensure that the equipment/validated as per the defined frequency.
• 确保设备/验证按照规定的频率。
• Ensure Continuous process verification as part of Product Life cycle management.
• 确保持续工艺验证作为产品生命周期管理的一部分。
• Ensure that the critical utilities such as (Potable water, Purified water, AHU, Compressed air/Gas, WFI, Pure steam) are sampled, qualified, and released as per the defined procedures.
• 确保关键公用设施，如(饮用水，纯化水，空调机组，压缩空气/气体，注射用水，纯蒸汽)按照规定的程序进行采样，合格，并释放。
• Ensure that the Aseptic process validation are executed as per the defined frequency and approved procedure.
• 确保无菌工艺验证按照规定的频率和批准的程序执行。
• Ensure that the Personnel working in the critical areas are qualified and monitored as per the defined procedure.
• 确保在关键区域工作的人员合格，并按照规定的程序进行监控。
• Ensure that the Environmental monitoring, WFI, PW, Pure steam, compressed air/Gas are trended.
• 确保环境监测，WFI, PW，纯蒸汽，压缩空气/气体的趋势。
• Ensure that all the critical alarms are monitored and trended.
• 确保对所有紧急告警进行监控和趋势。
• Ensure that all the personnel working in the GMP environment are trained as per their defined Job responsibility.
• 确保所有在GMP环境下工作的人员按照其定义的工作职责接受培训。。
• To organize for cause audits as and when required.
• 必要时组织原因审核。
• Adhere to the Safety, health and environment policies implemented at the site.
• 遵守在现场实施的安全、健康和环境政策。
• To coordinate with regulatory agencies and Regulatory department in addressing, deficiencies, compliance, queries, Notifications if any to the agencies.
• 与监管机构和监管部门协调，解决缺陷，合规，查询，如果有任何通知机构。
• Responsible for the release of Finished product manufactured at the site.
• 负责现场生产成品的放行。
• Responsible for ensuring that the trainings are carried out as per the approved training matrix.
• 负责确保培训按照批准的培训矩阵进行。
• Responsible for assuring mandatory trainings such as GMP, GLP, Data integrity, microbiology, clean room behavior trainings are carried out as per the approved schedule and frequencies.
• 负责确保强制性培训，如GMP, GLP，数据完整性，微生物学，洁净室行为培训按照批准的时间表和频率进行。
• Responsible for implementing the Quality culture across the site.
• 负责在现场实施质量文化。
• Any other assignment allocated by the Department head.
• 部门主管分配的其他任务。