Hisamitsu (Currently Noven Pharma) Work Values

Daily Duties at Hisamitsu (Currently Noven Pharma):

Variety of activities in Quality Assurance Department for supporting and implementing Quality Systems • Preparing / Transforming company to GMP activities, commercial manufacturing • Assisting QA Manager during Pre-Approval Inspection by FDA to obtain company GMP Licenses • Reviewing variety of GMP related documents including Batch Records, Stability Studies, Validation Protocols and Reports, Material Specifications, labels, QC testing, etc. • Writing and revising Quality System SOPs. Assisting/ reviewing SOPs for other departments • Managing or assisting the key QA systems: Change Control, Deviations, Investigations and CAPA, Document Creation / Change Control, Material Specification, Personnel Training Files, External and Internal Audits Files, QA Logbooks, Equipment Files and other • Performing Internal Audits • Managing equipment calibration and maintenance system

What they like about Hisamitsu (Currently Noven Pharma):

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Quality Assurance Manager, Quality Systems Manager, FDA regulated industry, GMP industry, CAPA, Deviations, Complaints, Change Control, OOS, Training, Equipment Calibration and Maintenance, Document Control (electronic and paper based), Test Method Validation, Equipment Qualification, Stability Program, FDA and ISO inspections, Audits (Internal and External)

Skills

P&L responsibilities, Presentation, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership

These are some of the questions we asked our climbers about their experiences with Hisamitsu (Currently Noven Pharma):