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Senior Executive, Process Engineering (QMS) at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

22 Apr, 26

Salary

0.0

Posted On

22 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

QMS Documentation, Change Control, Deviation, CAPA Concepts, WHO-GMP, EU-GMP, USFDA Basic Requirements, Data Integrity, GMP Awareness, GDP Awareness, English Reading & Writing, Deadline-Oriented, Process Mapping, Flowchart Making, Risk Assessment, Root Cause Analysis

Industry

Pharmaceutical Manufacturing

Description
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)
Responsibilities
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.