Job Opening

2 weeks ago

Ahmedabad Gujarat, India Zydus Group Full time

Department
- OINTMENT FACILITY QA
- Job posted on
- Dec 24, 2024
- Employment type
- P-P8-Probationer-HO Executive

Job opening - QA QMS - Zydus Lifesciences Ltd. - Changodar (Topical Plant)

Department - Quality Assurance

Designation - Officer/Executive

Experience - 2 to 5 Years

Job Description:
**1.** **1.** **Oversight Training and HR Admin**
- Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per data governance quality policy.
- Responsible for quality oversight of personnel and practice to meet the cGMP and compliance requirement.
- To ensure that employee is trained as per identified TNI (training need identification).

**2.** 2. **Deviation and Process Investigation**
- To participate in an investigation plan in consultation with department head, QA section in-charge and shall conduct investigation
- To recommend for quarantine or holding the product or materials affected (if required) until conclusion of required investigation(s).
- To propose an investigation plan and evaluate the impact of failure result(s) on already distributed batches/ batches under manufacturing or in staging area.
- To carry out impact assessment.

**3. Market Complaint Recall and FAR Cell**
- To receive the complaint and log the product complaint and adverse drug event (ADE) complaints with required details, site shall provide their complaint log number to central quality market complaint cell for updation of tracker.
- To prepare a draft response and send the same for review and comments by central quality market complaint cell.
- To prepare trend of complaints and compare the same against the historical data and to inform site QA head on emerging trends for repetitive complaints for product/nature/category.
- To participate in product recall investigation and ensure the implementation as well as effectiveness check of proposed CAPA.
- To track status of alert notification, follow up actions and its closure, status of investigation and response of logged complaints.

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