About the Company:
NewLife Medicals offers solutions that help pharmaceutical, CROs, nutraceutical, and biotechnology companies to accelerate business growth through clinical development, manufacturing, drug development and commercialization process. Our operations are spanning in more than 42 countries across the globe. We are supporting Sponsors, Research & Development centers, and Clinical Research Organization’s to build their drug development capabilities, by supplying the comparator drugs or RLDs from global markets.
Job Summary:
This position for Quality Management Systems (QMS) will ensure compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards in a warehouse environment specializing in clinical trial supplies. This role involves implementing, monitoring, and enhancing quality systems to maintain regulatory compliance and ensure operational excellence.
Essential Duties and Responsibilities:
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Manage and oversee the QMS processes, including documentation, control, and implementation of policies and procedures in compliance with GDP, 21 CFR, and industry standards.
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Conduct routine internal & external audits of warehouse operations to ensure adherence to quality guidelines, regulatory requirements, and standard operating procedures (SOPs).
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Coordinate and manage deviation investigations, CAPA (Corrective and Preventive Actions), change control processes and Risk Assessments.
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Ensure Vendor/Customer Verification & Qualification on timely basis also should do audit if required on site of partners site.
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Accurate documentation check for the each transaction been carried out for the inbound and outbound by the operation team.
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Ensure accuracy and effective maintenance of the eQMS portal for all quality-related documentation and activities.
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Reviewing and Authorizing Quality related documents and agreements.
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Prepare and review quality documentation such as SOPs using eQMS portal, validation protocols, and training records to ensure they meet regulatory and organizational standards.
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Support regulatory inspections, internal audits, and customer audits by providing necessary documentation and ensuring compliance readiness.
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Monitor and evaluate the effectiveness of QMS processes through metrics and reporting, identifying areas for improvement.
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Conduct training sessions for staff on QMS policies, GDP requirements, and regulatory compliance.
NewLife Medicals, Inc. -
Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory affairs, to address quality-related issues and implement improvements.
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Training the operation team personnel in warehouse.
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Stay updated on evolving regulatory requirements and incorporate changes into QMS practices.
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Yearly review on the SOPs if any changes need to be made and upgrade the processes.
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All documents record should be kept in controlled and secured manner.
Work Experience Qualifications:
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Proven 5+ years of work experience in QMS role within the Pharmaceutical Industry.
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Result driven orientation having solid customer service attitude with excellent negotiation skills.
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Previous experience in SAP & MS Office will be an added advantage
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Must have keen attention to detail and possess proper phone and email etiquette.
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Ability to stay organized while effectively prioritizing multiple projects at once.
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High attention to detail when completing projects.
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Person should be in position to travel for meetings and exhibitions and events.
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Strong time management skills to complete projects by deadlines.
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Self-motivated individual who takes ownership of their projects.
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Administrative skills (MS Office and Google Workspace are required).
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Maintain excellent verbal, writing, and language skills.
Education Qualifications:
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Masters’s Degree in health sciences, or related field of Pharmaceuticals.
Why You Should Join NewLife Medicals
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Join a high growth and fast paced global organization with a people focused culture
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Global exposure, defined career path and annual performance review and feedback process
NewLife Medicals fosters Respect, Equality, and Inclusivity within its employees, stakeholders, suppliers, and vendors. Our diversity plan recruits the best talent regardless of gender, age, race, disabilities, and nationality. This facilitates a diverse work culture where people with different skill sets come together to create an environment of creativity and mutual respect. Women represent half of our workforce.
We endeavor to create a sustainable value system for people, communities, partners, and our planet. We have established a compliance team that guides employees in following ethical business practices while incorporating integrity and honesty in their behavior.
NewLife Medicals encourages employees to make their lives productive while enjoying the workplace. We encourage them to bring their own goals and achieve them with us with our employee-friendly work policies, support system, safe environment, and growth opportunities. Celebrating life in every form is a core of every NewLife Medicals employee’s existence.
