Establish a process for reporting monthly on all audit activities across the Toxicology Business Unit.
Collaborate with Inspection Readiness primes in preparation of key Quality System audits and establish Inspection Readiness programs where required.
Participate as required in various audit support roles across the business unit during Quality System audits.
Support local Quality teams in meeting internal reporting requirements for audit activities.
Guide local Quality teams in establishing appropriate and effective investigation and corrective action plans stemming from audit observations.
Leverage audit quality metrics to identify risks for the organization to direct and support the development and implementation of policy, procedure, training, and other available tools for reducing identified risks.
Provide subject matter expertise to drive improvements and decisions relating to quality audits.
Carry out duties in compliance with established BU, Division, and Corporate Quality practices, policies, and processes.
Periodic travel to Toxicology entities will be expected.
EDUCATION AND EXPERIENCE YOULL BRING
Education BSc Degree in Chemistry, Biochemistry, Biotechnology or related
Minimum 5 years in a Quality role, with proven experience in managing regulatory Quality System audits in a medical device or similar environment
Demonstrated experience in quality systems and regulatory compliance including expertise in 21 CFR 820, ISO 13485, and 17025.
Professional certification is preferred (i.e. CQA, Six Sigma, CQM)
Possess strategic perspective and be capable of synthesizing information and prior experience from multiple sources to build efficient and successful quality strategies for the organization
Be skilled in interpreting quality requirements and converting these into practical and pragmatic actions
Ability to work effectively in a cross-functional/cross-site environment, achieving regulatory compliance through teamwork, facilitation, and influence
Demonstrated great written and verbal communication skills, including the ability to articulate complex regulatory/quality arguments with clarity
Someone who is well organized and attentive to detail, strong interpersonal skills, and capable of providing support and direction to others
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives, and retirement plans
Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and a history of being actively involved in local communities
Function : Quality/Process Control
Specilizations: Quality Assurance, Quality Control
JOIN US AND EXPERIENCE "GROW WITH THE LEADER"
In India, Abbott values our people and delivers key employee and talent priorities. Our India Talent Strategy sets out our employee value proposition, where we create a transformational journey and offer opportunities for our people to grow and build successful careers at Abbott.
Join us and experience "Grow with the Leader". This is brought to life through three guiding principles:
Be Acknowledged for Your Effort
Be the Best You Can Be
Be Inspired by What You Do