Senior Executive / Assistant Manager QA-LLS @ Linux Life sciences

Job Description

Job description

• Preparation of BMR & BPR
• Preparation of master formula record ( MFR )
• Implementation of new SOP in a site.
• Artwork checking as per the current guidelines.
• Preparation , Issue , retrieve and review the BMR & BPR
• Implementation of the IPQA activities and report duty to the Head QA
• Issue of log sheet & formats and retrieval of the same.
• Issue and receive the log sheet for Environmental monitoring, Balance calibration, Preventive maintenance and other related formats to various departments as per the predetermined schedule
• Preparation of Process validation and cleaning validation protocol accordingly conducting sampling for Process Validation ( PV ) & Cleaning Validation ( CV ) . Preparation , consolidation of validation reports.
• Monitor the compliance of SOP
• APQR preparation.
• Able to provide QMS training to the subordinates.
• Maintaining cGMP documents in the plant
• Ensure the Internal & External Calibration
• In process checks during manufacturing and packing activities
• Co ordinate with Internal & External ,Regulatory Audits
• Co ordination with change control & Deviations
• Implementing the Requirement of Quality Management System ( QMS)
• Ensure the equipments in Production and Utilities confirmed with Preventive Maintenance as per the schedule. And etc,..

Preferred candidate profile B, Pharmacy with relevant Experience in Pharmaceuticals Formulation Company
Perks and benefits
As per industry standard

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