About this role
- To prepare draft relevant to QMS element (i.e., CCF, CAPA, Deviation, OOS etc.) and complies it with approval of QA.
- To prepare SOP for Operating & maintenance activities related to Maintenance department.
- To interact with QMS department for completion of deviation, CCF, CAPA and other activity related to Maintenance department.
- Tracking Monitoring of QMS element to compliance in time.
- Lead DTC role for the compliance training system engineering section.
- Follow-up with concern to compliance related to QMS element of maintenance.
- Maintain, organize, and coordinate maintenance documentation in department and Doccell.
- Maintain Departmental MOM, Manpower, and external communication documents.
- Report on daily basis to immediate superior
Skill :
- QMS Documentation : Proficient
- Change Control, Deviation, CAPA concepts : Proficient
- WHO-GMP / EU-GMP / USFDA basic requirements : Proficient
- Data Integrity (ALCOA+ principles) : Proficient
- GMP, GDP Awareness : Proficient
- English reading & writing strong (mandatory)
- Deadline-oriented
- Process mapping & flowchart making
- Risk assessment basics (FMEA / Risk Matrix)
- Root Cause Analysis (5 Why, Fishbone – basic level)
Other facts
About Amneal India
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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What you'll do
- The Senior Executive, Process Engineering (QMS) is responsible for preparing drafts related to QMS elements and ensuring compliance with QA approval. The role also involves maintaining and organizing maintenance documentation and tracking compliance of QMS elements.
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