• Lead/participate in project team to streamline Clinical QA processes and SOPs by reviewing existing workflows and identifying areas for improvement.
• Perform SOPs periodic review, write/revise SOPs and design process flowcharts
• Responsible for ensuring CAPA/ audit observations responses are appropriately implemented and closed in a timely manner
• Coordinate inspection and audit support for Clinical QA during internal / regulatory inspections and audits
• Manage Clinical QA training requirements and curricula, OJT qualification programs, and New Employee Onboarding programs to drive improved employee qualification and training compliance
• Maintain systems for organizing, tracking, trending and reporting Deviation, CAPA, batch disposition and review metrics
• Review existing quality workflows and assist in identifying areas for improvement. Write, revise and may review standard operating procedures.
• Other responsibilities as assigned
• In depth knowledge of Quality Systems and international cGMP standards
• In depth knowledge and experience with Operational Excellence Principles
• An accountable team player who is detail and quality oriented with an in-depth understanding of quality assurance principles, systems and procedures
• Excellent attitude with good verbal and interpersonal communication skills, excellent judgment, and multitasking skills who can work well in a dynamic environment
• Strong leadership and negotiation skills
• An accountable leader who is detail and quality oriented with a solid understanding of quality principles, methods, and procedures
• Critical and strategic thinking skills
• Working knowledge of GMPs and regulatory requirements (US, Canada, and EU)
• Experience generating key metrics
• Technical writing skills
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.
Thank you.
Kind Regards,
Harris Kaushik
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - (732)-844-8715
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.