Production Qms

3 weeks ago


Ahmedabad Gujarat, India Zydus Group Full time

Division
- OINTMENT FACILITY
- Job posted on
- Feb 02, 2024
- Employee Type
- C-C7-Confirmed-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 self-inspection, 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 day-to-day 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**: 10 - 15 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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