Inspection Readiness Specialist
Job
12293 Haleon US Holdings LLC
Oak Hill, WV (In Person)
$130,836 Salary, Full-Time
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Job Description
Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter
- one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands
- including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum®
- lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose
- to deliver better everyday health with humanity
- at the heart of everything we do.
Key responsibilities:
Demonstrate expert knowledge and ownership in key quality responsibilities below: Enhance the site inspection readiness program by: ensuring cross-functional inclusion of key SMEs are occurring to keep the site in ready inspection mode at all times; maintaining a frequently evaluated 'top issues' list of topics to be prepared to speak to during an inspection; ensuring frequent Gembas of the processes to understand the current state for any emerging top issues. Manage and Support FDA and other regulatory inspections for the site; write and coordinate the issuance of a timely response to the Agency for any observations; and manage completion of commitments. Host Internal Corporate; write and coordinate the issuance of a timely response for any observations, including follow-up reports. Manage internal commitments to ensure timely follow-up and completion as committed to the audit functions. Maintain Site Internal Audit and Self-Inspection programs. Communicate effectively and establish processes to ensure smooth communication within the department, across functions and across sites. Ensure two-way communications between Site Leadership and the department. Approve GMP related documentation such as SOPs, CCs, Deviation, Validation/Qualification documents and Technical Reports. Approves any changes associated with these documents. Qualifications and skills Essential There is a range of educational experience allowed based on pharmaceutical experience obtained: Bachelor's degree in science or relevant field and 5 years of experience in a regulated GMP industry Preferred Knowledge of cGMP's/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11. Demonstrate initiative and analytical problem-solving skills- ability to use and interpret data to drive decision making at both tactical and strategic level.
- all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people.
Haleon Careers:
Job Accommodation Request' Your Name and contact information Requisition ID and Job Title you are interested in Location of Requisition (city/state or province/country) Description of specific accommodation you are requesting Please note: Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted. Note to candidates The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch. Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter- one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands
- including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum®
- lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose
- to deliver better everyday health with humanity
- at the heart of everything we do.
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