Officer at Amneal India

, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

01 May, 26

Salary

0.0

Posted On

31 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Machine Clearance, Sampling, In-Process Checks, AQL Sampling, ANSI Sampling, GMP Practices, Raw Material Dispensing Verification, Batch Coding Approval, Batch Record Review, CPV Data Trend Preparation, Impact Assessment, Change Control Initiation, Deviation Initiation, Environmental Monitoring Record Review, IPQA Instrument Calibration, SOP Preparation

Industry

Pharmaceutical Manufacturing

Description

To perform Machine and area clearance during dispensing, manufacturing and packaging operation. To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in-process samples and to manage sampling aids. To carry out in-process checks, AQL and ANSI Sampling as per respective documents viz. protocol, BMR, BPR, SOPs and other GxP documents. To ensure GMP practices at manufacturing shop floor. To verify raw material dispensing activity. To approve batch coding details during packaging operation. Review of executed batch records and release for next processing stage. Preparation and review of CPV data trend. To perform impact assessment of breakdown memo. To initiate change control, unplanned and planned deviation where ever required. To review area, equipment and cleaning log and to ensure proper labelling. To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records. To perform calibration of IPQA instruments. To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials. To review and approve packaging artworks, proofs and shade cards. To archive executed documents like BMR, BPR, Hold time Protocol etc. To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging. To monitor and record the environmental condition of label control room. To prepare and revise functional SOPs, wherever required. Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HOD'S instructions and guidance.

Responsibilities

The role involves performing machine and area clearance during operations, conducting various types of sampling, and executing in-process checks according to GxP documents. Responsibilities also include ensuring GMP compliance, verifying raw material dispensing, reviewing executed batch records, and managing quality documentation like change controls and deviations.