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Production Qms
2 weeks ago
- OINTMENT FACILITY
- Job posted on
Feb 02, 202
- Employee Type
- C-C7Confirmed-HO Staff
- Experience range (Years)
- 10 years 15 years
Basic Details:
-
Position title (if any):Production QMS**
Designation: Asst.
Manager/ Dy. Manager**
Reports to :Head of Department
Department:
Production
Location:
Zydus Lifesciences Limited, Changodar (Topical), Ahmedabad.**
Key Job Description:
- To follow the cGMP with the available infrastructure.
- To do the work as per cGMP and GDP.
- Review of documentation
- Review Batch Records and Standard Operating Procedure, Documents, Validation Protocol and review and approve.
- Implementation of corrective actions and preventive actions.
- To perform selfinspection, assist in failure investigation, market complaints investigation.
- Handling of change control, deviation, CAPA and incident.
- To investigation of product failure, system deviations.
- Tracking of implementation of commitment to various audit observations including internal audit observations.
- To inform department Head/plant head for any abnormalities i.e. deviations/events/safety events and for other daytoday activities and to participate in investigation activities.
- Responsible for QMS handling Initiation/Closure and closure related to Production (CAPA, Track Wise)
- Preparation of Risk assessment /Protocol
- To maintain timeline for all concerned activity.
- To ensure completion of activities as per requirement.
- To coordinate and synchronize product measurement within the department.
- To ensure compliances to all regulatory, internal audits.
2. Requirements
Qualification:
B. Pharm/M. Pharm
Years of Experience:
years
Experience / Exposure in:
Must have knowledge and experience in regulatory audit
Should have faced regulatory audits like USFDA, MHRA, MCC and ANVISA etc.
From which departments, people can apply:
Production
-
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