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Executive, IPQA at Amneal India

, , India -

Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

0.0

Posted On

14 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Compliance, Dispensing Activities, Label Issuance, Machine Clearance, Sampling, In-Process Checks, Document Review, Calibration, Batch Packaging, Environmental Monitoring, Logbook Management, Stability Studies, SOP Adherence, Quality Assurance, Record Keeping, Process Validation

Industry

Pharmaceutical Manufacturing

Description

cGMP and compliance review in the warehouse & packaging area as per cGMP guideline. Supervision of dispensing activity of raw material and packaging material. Issuance of Bottle label, outsert and Medication guide for commercial batch as per SOP. Machine and area clearance related to dispensing activities. Machine and area clearance, Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Process Validation Protocol (PVP), Batch Packaging Record (BPR) and stability study protocol. Documents and records review like equipments logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc. Online Review of Executed batch packaging record. Calibration of IPQA instruments.

Responsibilities

The role involves overseeing cGMP compliance and dispensing activities in the warehouse and packaging areas. It includes reviewing documents and records, as well as ensuring proper machine and area clearance during batch packaging.