IPQA Officer - Topical Unit

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 Job Description:

• To follow the cGMP with the available infrastructure.

• Online batch documentation with good documentation practices.

• To maintain proper planning, scheduling and achievement of production with optimum utilization of resources.

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

• Work distribution & optimum utilization of manpower in concerned area

• Issuance of control documents from QA

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

• Handling of change control, deviation, CAPA and incident

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

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

• To perform random checking desktop policy and to ensure housekeeping of system and area

• 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

• To review and approve PPQ protocol and report to verified the executed data and review summary report

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