||• Monitor manufacturing operations to ensure compliance with the relevant SOPs and cGMPs
• Manage Deviations/CAPA System
• Manage Retain Samples Program
• Manage Sampling processes- use of appropriate sampling plans and perform sampling of incoming materials and finished product
• Manage Supplier’s Management Program
• Participate in external vendor and labs audits and internal audits
• Assemble, review and maintain manufacturing documentation, validation protocols and reports etc.
• Perform ROSS ERP System inventory transactions
• Perform Document Control functions and administer changes in Agile Document Management System
• Participate in the development of protocols/reports in support of equipment and process verifications and validations
• Generate metrics and quality reports and maintains databases, prepare and trend product and process quality metrics
• Generate/revise procedures
• Participate in regulatory inspections
• Collaborate with Quality Control, Manufacturing, R&D, Regulatory, Engineering, and Supply Chain to ensure quality standards are met
• Alert management of product quality trends and significant observations.
• Review practices and provide recommendations for procedures and process improvements
• Strong attention to detail
• Strong verbal and written communication skills Strong communication , both spoken and written , interpersonal and negotiating skills to influence outcome and coordinate activities cross-functionally
• Strong organizational and prioritization skills to manage responsibilities in rapidly changing environment
• Experience in medical devices and/or drug manufacturing desirable
• Knowledge of manufacturing equipment and processes validations
• Ability to work in controlled, classified environment
• Proficient computer skills
• Leadership skills to train and to provide guidance to lower level personnel.
• Exercise good judgment within broadly defined practices and policies to evaluate and solve problems; decisions may have impact on product, on programs and cross functional success.
Education and Experience:
• BS/BA in life sciences or related discipline
• Min. 8 years cGMP experience in a technical role in Quality Assurance and 3 years QE role in the medical device, pharmaceutical or biotech industry compliant to U.S. FDA 21CFR820, 21CFR 210/211.
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