Job 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)
Qualifications
Educational qualification: B.Tech / BE (Mechanical / Electrical / Instrumentation)
Diploma + relevant experience (QA / Documentation) Experience: 5 Years (With Documentation)
Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.
