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1.0 - 5.0 years
2 - 3 Lacs
sonipat, rai
Work from Office
1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries 2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO14971:2012 & Medical device Rules 2017. 3. Demonstrated success in a start-up, entrepreneurial work environment 4. Thorough knowledge of FDA Quality System requirements, ISO 13485:2012 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
Posted 1 month ago
5.0 - 7.0 years
8 - 11 Lacs
Sonipat, Rai, Industrial Area
Work from Office
To prepare packing schedule and plan packing activities in order to achieve packing targets. Responsible for process line, prepare schedule for repair, over hauling and maintenance of all VFFS packing machines (Vertical Form Fill Seal machine) Candidate should have work in in the flexible packaging i.e Pillow Pouches, Stand-Up (Standy) Pouches, and Gusset Pouches To allocate resources like Manpower Resources, Raw Material, Equipment & machinery to achieve the packing targets and optimize the output. To monitor the process as it should be as per GMP, SOPs and Company policies and Procedures To co-ordinate with QC department for ensuring the quality of Raw materials, Intermediates & Finished p...
Posted 2 months ago
1.0 - 5.0 years
2 - 3 Lacs
Sonipat, Rai
Work from Office
1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries 2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO14971:2012 & Medical device Rules 2017. 3. Demonstrated success in a start-up, entrepreneurial work environment 4. Thorough knowledge of FDA Quality System requirements, ISO 13485:2012 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
Posted 4 months ago
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