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IPQA

IPQA

Syngene

2 - 5 years

3 - 7 Lacs

Bengaluru

Posted:1 day ago| Platform:

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Skills Required

Operating systems IPQA External audit Quality systems Shop floor QMS Downstream processing Process equipment Auditing Quality management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Skill set requirement:

Experience in DS manufacturing activities (upstream & downstream process) of biological products (Preferably mAbs).

Should have knowledge on line-clearance process of DS manufacturing activities.

Should have understanding on audit trails verification of GxP computerized systems.

Understanding on process equipment handling & operating systems.

Understanding on WH activities like material receipt, dispensing and handling of rejected materials.

Basic understanding on cGMP regulations.

Cross functional review for CC, CAPA pertaining to Facility, utility, Equipment s, process and procedures.

Participate in internal & external audits at shop floor.

Provide the data for Quality management review/Quality governance forum as applicable.

Scheduled cGMP compliance verifications for BMP facility & utility areas as per SOP.

Periodic review and approval of trend reports (EMS, NVPC) and review of system generated report s (Ex: EMS, NVPC, Deep freezer, Freezer, Cold rooms, LN2 systems).

Supporting QMS team for investigations and other quality systems.

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