Job Description Summary
The purpose of this position is to support:
• The projects ensuring its timely completions thru product testing, statistical data analysis and documentation of the projects complying to quality system requirements.
• The manufacturing processes by addressing quality issues such as process rejections, customer complaints and CAPA thru systemic root cause analysis and suitable corrective actions.
The validation related activities such as compliance to validation procedure, review the validation documents including plans, reports and the applicable QMS documents including Buy Specifications, FMEA, Control Plan and operating SOPs.
Job Description
Job Responsibilities
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- Developing and documenting plans for engg feasibility study, process optimization, MSA and process validations.
- Organize the product testing, MSA, collect test data & perform data analysis.
- Participate in project meeting, develop strategies for projects and project plans.
- Perform and document root cause analysis and propose corrective actions, verify effectiveness of the implemented corrective actions.
Knowledge and Skills:
- GMP & ISO 13485
- Regulatory Requirements - MDD, Indian Drugs and Cosmetic Act 1940
- Familiar with key statistical tools for data analysis preferred to be Green Belt - Six Sigma
Required Skills
Optional Skills
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Primary Work Location
IND Rewari - Bawal
Additional Locations
Work Shift