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Not Disclosed by Recruiter Openings: 1 Posted 30+ days ago Job Applicants: 65 Job Views: 473

Job Description

 
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    Major Roles & Responsibilities:

    To prepare/ update the error free and user friendly documents. Standard Operating Procedure (SOP) preparation and updation according to cGMP , to cross-check implementation of SOP for production and report to Sub-Department Manager of Production and Quality Assurance (QA) , if the deviation is observed. Handling of QMS documents and follow up to its closure in defined time line:

    •To initiate the change in process, equipment or facility as per time to time requirement and perform impact assessment for own and other functions change controls.

    •To ensure the timely implementation of CAPA, to attend the CAPA meeting and prepare the CAPA response.

    •To access the impact of functional and cross functional deviation and OOS in co-ordination with area manager and ensure completion in time. To impart the training to production and packing personal, cross functional training where ever required. Review the BMR and BPR with area managers to update/ revise for betterment of documentation practice on shop floor. Review the filled BMR and BPR before submission to QA. Document preparation for cGMP inspections and preparation of response to the inspection findings in co-ordination with sub departmental manager/ head of department. Communicate any abnormality related to documents to production / packing executive. Communicate any delay of document to respective department representative. Maintain the production consumables and coordinate with purchase department and other relevant department to accomplish the task. Highlight the mistakes and forward to sub departmental manager/ head of department for further action. Stop the activity in case of any critical abnormality or any documentation not done online and inform to respective area manager for rectification. Escalate any delay in execution of change control and CAPA generated through QMS investigation. To record all the activities in the approved formats at the time of observation/ activity is performed. To have thorough knowledge of SOP of own working area and ensure to practice it. To follow clean room behaviors strictly. Ensure the housekeeping of the area is in controlled state. Ensure all safety norms are followed in respective area. Keep self and team updated about CGMP requirement. Ensure completion of all required training for self as well as team.

    Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for

Salary: Not Disclosed by Recruiter

Industry: Medical, Healthcare, Hospitals

Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology

Role Category:Medical Professional

Role:Pharmacist/Chemist/Bio Chemist

Employment Type: Full Time, Permanent

Keyskills

Housekeeping QA SUB Manager Quality Assurance Shop floor Sop preparation QMS Housekeeping Executive Executive Packaging Process equipment

Education-

UG: Any Graduate - Any Specialization

PG:Post Graduation Not Required

Company Profile:

Baxter India Pvt. Ltd.

A leader in healthcare for more than 75 years. Baxter assists healthcare professionals and their patients with treatment of complex medical conditions. Information on our business and leadership is available here.
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