This position will provide Quality Assurance oversight to one or multiple operational areas as a Quality Representative supporting Neolpharma and Cediprof operations. The role is responsible for performing quality-related activities in accordance with company procedures and applicable regulatory requirements. The employee will provide guidance on compliance matters, actively support functional area goals related to compliance, and communicate updated regulatory trends and required actions to maintain operational compliance.
- Reviews and approves procedures, protocols, reports, and other documents requiring Quality Assurance oversight.
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Reviews and approves manufacturing and packaging records, as applicable.
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Ensures compliance with corrective and preventive actions (CAPAs) resulting from event reports.
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Reviews and approves investigation reports, ensuring root causes are identified and appropriate CAPAs are established.
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Performs statistical analyses, including trend and variability evaluations, and prepares quality metrics as required.
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Supports the Annual Product Review (APR) and Quality Record Review programs.
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Ensures product complaints are properly investigated and corrective actions are implemented.
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Provides Quality Assurance support for new product transfers within assigned operational areas.
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Reviews and approves change controls for assigned areas.
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Monitors open and overdue quality records/documents to ensure timely resolution and mitigation of compliance risks.
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Provides guidance on the implementation of new regulatory requirements and industry guidelines into area procedures.
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Supports regulatory and client inspections/audits, including FDA, MHRA, ANVISA, DEA, and customer audits.
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Performs spot audits within supported functional areas to ensure compliance with procedures, documentation practices, and cGMP regulations.
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Coordinates inspection activities with clients, inspectors, regulatory agencies, and internal departments regarding quality-related matters.
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Participates in new employee onboarding and provides training on cGMP requirements.
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Actively participates in the identification and prevention of root causes related to investigations and operational discrepancies to ensure sustainable corrective actions.
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Supports manufacturing and product release schedules established during planning meetings.
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Receives and processes license renewals and follows up on renewal documentation, as applicable.
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Prepares required communications and reports for regulatory agencies, including FDA, MHRA, ANVISA, and DEA.
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Ensures all reviewed site procedures comply with established formatting and content requirements.
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Performs other duties as assigned.
- Bachelor’s degree in Science, Engineering, or a related field.
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Minimum of three (3) years of experience in the pharmaceutical industry.
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Strong knowledge of solid oral dosage manufacturing and laboratory operations, depending on the assigned functional area.
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Experience with validation concepts and activities, including Process Validation, Cleaning Validation, Analytical Method Validation, and Utilities Qualification.
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Knowledge of local, federal, and international regulations applicable to the pharmaceutical industry.
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Experience conducting and evaluating investigations, deviations, and discrepancy reports.
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Demonstrated ability to interact effectively with internal and external customers.
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Fully bilingual in English and Spanish (written and verbal).
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Strong verbal, written, interpersonal, and organizational communication skills.
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Ability to manage changing priorities in a fast-paced and regulated environment.
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Strong organizational, prioritization, planning, and problem-solving skills.
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Proficiency in Microsoft Office and other business-related applications.
- In-depth understanding of cGMP regulations, EHS requirements, and other applicable regulatory standards.
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Knowledge of controlled substances regulations and compliance requirements.
This position will provide Quality Assurance oversight to one or multiple operational areas as a Quality Representative supporting the Neolpharma and Cediprof operations. This role will perform all related quality activities as established on Company procedures and applicable regulations. The employee will provide guidance on compliance aspects and will actively participate in functional area goals regarding compliance. Provide information of updated compliance trends and follow up actions required for keeping the operation in compliance with regulations.
EOE/AA/Females/Disabled/Veterans
Apply: http://www.neolpharmapr.com
