Job Description

Basic Details:-

Position title (if any) : IPQA Officer

Designation : Officer/Executive

Reports to : Head of Department

Department : QA

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

1. Key :

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

\xc2\xb7 Online batch documentation with good documentation practices.

\xc2\xb7 To maintain proper planning, scheduling and achievement of production with optimum utilization of resources.

\xc2\xb7 Co-ordinate the activities with subordinate, maintain working as per requirements and supervision of related activities in department

\xc2\xb7 Work distribution & optimum utilization of manpower in concerned area

\xc2\xb7 Issuance of control documents from QA

\xc2\xb7 Preparation & Implementation of Batch Records and Standard Operating Procedure, Documents, Validation Protocol and review and approve

\xc2\xb7 Handling of change control, deviation, CAPA and incident

\xc2\xb7 To co-ordinate with all departments i.e. with QC, QA, Eng., HR and GDSO

\xc2\xb7 To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms and events as per site SOP.

\xc2\xb7 To perform random checking desktop policy and to ensure housekeeping of system and area

\xc2\xb7 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

\xc2\xb7 To review and approve PPQ protocol and report to verified the executed data and review summary report

2. Requirements

Qualification: B. Pharm/M. Pharm

Years Of Experience: 04 - 08 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

Mail your CVs to: hr.topical@zyduscadila.com,Upendrasinh.Zala@zyduslife.com

Zydus