- Contract Duration 4+ months
Job Summary:
- Understanding the terminology or equipment for someone who has never worked in this space before.
- Nothing that can't be learned.
- There will be structure, the candidate needs to be organized
- Microsoft Office and PowerPoint, SAP plus, excel
Job Requirements:
- Computer literate & proficient in Microsoft Office Suite, Electronic QMS, and SAP systems
- Exhibit professionalism and foster teamwork to create an environment of support that leads to the productivity of R&D personnel and ensures GxP compliance.
- Ability to interpret and assess operational compliance against Good Manufacturing Practice Regulations (FDA, KFDA, HC, ISO22716)
- The QA Specialist maintains awareness of current GxP trends and regulatory authority expectations.
- Leading training on key quality topics like GXPs,
- Experience in Fast Paced Consumer Goods manufacturing environment a plus (Cosmetic, Food, or Pharma)
- Experience in a GMP-regulated environment preferred
- The candidate must be able to work independently
- Knowledgeable of Cosmetic & OTC drug product regulations & implementation of Quality Management System (QMS)
- Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications, drawings, and compounding/assembly instructions
- The QA Specialist's ability to utilize standard tools and equipment (such as scale, fill weight, cap torque, viscometer, pH meter, pull force, seal burst, and other relevant equipment)
- Ability to review SOPs, GMP reports, batch records, and investigations
- Ability to execute/coach teams in Root Cause problem-solving & associated Corrective & Preventive Actions (CAPA)
- follow through, implementation of corrective and preventive measures, a compilation of quality metrics, reviews/approval of raw materials specifications
- troubleshooting ability and Root Cause investigation experience.
- Expertise in R&D, Manufacturing, or Process development is required
- Implement, maintain, and continuously improve the R&D GMP Quality Management System
- Ability to identify and drive process improvement opportunities by partnering with cross-functional stakeholders
- Ability to execute, summarize and manage process audits in the manufacturing areas
- Effective oral and written communication skills and ability to appropriately communicate information to cross-functional stakeholders and suppliers
- Requires effective communication skills (oral, written & non-verbal) to direct R&D personnel and discuss quality-related issues with management.
- Oversee document control/archiving processes
- The ability to work on multiple projects and the flexibility to adapt to changing priorities are a must. Must possess strong organizational and planning skills
- creation/revision/review of SOPs, administration of Change Management
- timely completion of deviations and investigations, out of specifications investigations
- reviews and approvals of batch records, validations protocols, and reports, etc.
- Data Integrity, Validation, documentation controls, quality root cause analysis, etc. Lead internal audits and support external audit processes. Responsible for informing management of quality issues in a timely manner.
About The Company:
- Our client is one of the world's leading manufacturers and marketers of quality skincare, makeup, fragrance, and hair care products with over half a billion consumers a year in over 150 countries. The company embraces the challenges of leading in the ever-changing beauty landscape, and its competitive nature is a powerful source of motivation. They focus on long-term growth with an ability to execute with agility and excellence. The company prides itself in offering a stimulating inclusive environment that fosters creativity, innovation, and integrity in everything they do.
- At this company, they aspire to foster their heritage of respect and be a positive influence in everything they do and in every community they serve. Corporate citizenship and sustainability are central to its beliefs — from employee volunteerism and their cause-related campaigns to the creation of high-performing and safe products, all while caring for people and the environment.
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