Assistant Manager – Production QMS | Zydus Lifesciences | Ahmedabad

Job Description

Roles and Responsibilities:

•   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, and Validation Protocol and review and approve.

• Implementation of corrective actions and preventive actions.

• To perform self-inspection, assist in failure investigation, and market complaints investigation.

• Handling of change control, deviation, CAPA, and incident.

• To investigate product failure, and system deviations.

• Tracking of implementation of commitment to various audit observations including internal audit observations.

• To inform department Head/plant head of 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 a timeline for all concerned activity.

• To ensure completion of activities as per requirement.

• Coordinate and synchronize product measurement within the department.

• To ensure compliance to all regulatory, and internal audits.

Desired Candidate profile:

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 ANVISA, etc.

Position Summary:

Position title:  Production QMS

Designation: Asst.Manager/ Dy. Manager

Reports to: Head of Department

Department: Production

Location: Zydus Lifesciences Limited, Changodar (Topical), Ahmedabad.