IPQA Assistant Manager

Roles and Responsibilities.

Responsible for ensuring CGMP compliance on shop floor.

Responsible for line clearance during Dispensing, Manufacturing, and Packing.

Responsible for performing in-process checks during different stages as Dispensing, Manufacturing, and Packing.

Responsible for AQL inspection.

Responsible for Sampling of process validation batches and Cleaning validation as per sampling plans defined in protocol from different stages and different location of process.

Responsible for sampling at different stages of manufacturing and packing and submitted the sample to QC/QA.

Responsible for Quarantine management.

Responsible for daily Balance verification and monthly calibration.

Responsible for stage wise release of batches through LIMS and ERP.

Responsible for stage wise generation of under test and approved label through ERP and affix the label on product container label.

Responsible for request generation and printing of additional pages of BMR /BPR through EDCS.

Responsible for pack stock checking and verification at finished product.

Responsible for verification of Finished Good Transfer Note.

Responsible for on line review of executed log books and BMR /BPR.

Responsible for on line review e-log entries on a daily basis.

Responsible for Handling of Incident/Deviation change control and CAPA.

To ensure that the entry & exit procedures, gowning (Primary & Secondary, color code) procedures, Personnel Hygiene procedures are followed strictly.

Desired Candidate Profile

• Candidate should have relevant experience in the pharmaceutical Industry, preferably in Solid Oral Formulations and have regulatory exposure to USFDA.
• Should have excellent verbal & written communication skills.
• Ability to work in dynamic environment.
• Should be assertive, proactive, and self-driven.

Interested candidates can reach out at pratik.joshi@acmegenerics.in (9909998982)