Kashiv BioSciences

About Kashiv BioSciences

Overview: This QA Associate will be responsible for supporting Kashiv BioSciences Quality Assurance management in reviewing, implementing and managing the quality system to ensure overall product and process quality. As an integral quality team member, this individual will provide assurance that all products and quality system processes in the facility are in compliance with cGMP requirements and company policies and procedures Responsibilities: Provide QA support during manufacturing operations. Perform Raw Material sampling, In-process and Finish Product sampling and coordinate submission of samples to QC analysis. Receiving of external samples and log in internal quality system Assist all departments in the generation of quality system documentation; such as SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, and change controls. Assist in document control activities (training records entries, logbook issuances, logbook archival etc.) Quality release of raw materials and finished products. Review of documentation supporting batch, warehouse, metrology, engineering and validation activities to ensure they are complete and in compliance with company policies and procedures, and cGMP requirements. Perform quality assurance walk-through audits of manufacturing, laboratory and warehouse areas to ensure compliance with cGMP requirements and company procedures. Interface with cross functional departments to resolve quality issues. Complies with all company policies and standards Performs other functions as required or assigned Ensure adherence to GMP good documentation practices Support QA function in additional jobs assigned by Supervisor as and when required Qualifications: Ability to work independently or in teams both within department and cross-functionally. Must be able to organize, plan and manage assigned tasks to bring projects to completion. Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferable Experience in GMP document control Understand the requirements and procedures related to document control and Quality Assurance. Ability to work with teams - good interpersonal skills. Strong communication skills: verbal and written. Organization and time management skills, detail oriented. Good computer skills, including in depth knowledge of Word, Excel and spread sheet software required. Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete. Education:*Bachelor's degree*Minimum of 2 years of relevant experience in the pharmaceutical industry

Synonyms

Technologies (from Job Ads)

Hiring Locations

Headquarters

Loading map...

Company Info

Legal Form: LLC

Job Ad Metrics

Job Ads found: 90

Job Ads per Month: 3.1

Hiring Locations: 3

Data Info