Job Description

ZTMP TEMPLATE FORMAT TO SHARE REQUIREMENTS

Basic Details: -

Position title (if any) : QA - QMS (Investigation, Training)

Designation : Asst. Manager

Reports to : Head of Department

Department : Quality Assurance

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

• Key :

\xc2\xb7 To follow the cGMP with the available infrastructure.

\xc2\xb7 To do the work as per cGMP and GDP.

\xc2\xb7 Review of documentation.

\xc2\xb7 To ensure proper & complete documentation in the department.

\xc2\xb7 Preparation of Standard Operating Procedure, Documents, Validation Protocol and review and approve.

\xc2\xb7 Implementation of corrective actions and preventive actions.

\xc2\xb7 Ensure adherence to relevant SOPs for specific job.

\xc2\xb7 To investigation of Market complaint, product failure, system deviations.

\xc2\xb7 To coordinate with all departments i.e. with Q.C., Production, Warehouse, Engineering, IT, HR-Admin. for training related activities, planning, data maintenance and ensure compliance pertaining to training.

\xc2\xb7 Handling of Market complaint and CAPA.

\xc2\xb7 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.

\xc2\xb7 Responsible for QMS handling Initiation/Closure and closure related to Production (CAPA, Track Wise)

\xc2\xb7 Preparation of Risk assessment /Protocol.

\xc2\xb7 Overall responsibility of Training related activities at site.

\xc2\xb7 To ensure completion of activities as per requirement within stipulated timeline.

\xc2\xb7 To ensure compliances to all regulatory, internal audits.

2. Requirements

Qualification: B. Pharm/M. Pharm

Years of Experience: 05 - 10 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:

Quality Assurance

Mail your CVs to: , Rajani.Pratap@zyduslife.com

Zydus