Work for one of the most respected names in the pharmaceutical industry! This global manufacturer of over 1500 products, servicing over 100 countries is looking for a QA Validation Specialist to join their team in Central Islip, NY.QA Validation SpecialistResponsibilities
- Responsible for providing Quality Assurance support for receiving/releasing GMP documentation of bulk drug substances and finished drug products
- Review documentation for manufacturing activities associated with commercial, development, and engineering execution per good documentation practices (GDP), including but not limited to executed batch records, master batch records, product labels, and product-specific documents
- Independently executes batch record review for completeness, accuracy, and cGMP compliance.
- Critically review various documentation types to ensure completeness, accuracy, and compliance including but not limited to test methods, method validation protocols , reports and SOPs
- Compile and report performance metrics for Batch Review and Release
- Oversee the status of batches through the disposition/release process and remove barriers, communicate escalations as appropriate
- Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, and create/revise relevant SOPs.
- Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.
- Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met.
- Communicate effectively with cross-functional departments to ensure on-time delivery of QA review and disposition responsibilities.
- Prepare reports and keep upper-level management informed of progress, act as QA reviewer for investigations, deviations, and CAPAs as appropriate and designated by QA Management.
- Collaborates with Manufacturing to resolve document discrepancies or errors as it relates to Good Documentation Practices.
- Perform tasks in a manner consistent with all company policies including safety (EHS), quality systems and cGMP requirements.
- Understand risks and delays to batch release and communicate appropriately.
- Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent the Batch Disposition QA perspective as needed.
- Works in a collaborative team setting within the Batch Disposition team, within the quality department, and with quality counterparts including Manufacturing Operations, Technical Support, Supply Chain, and Planning.
- Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of products.
- Ability to quickly process complex information and make critical decisions with limited information required.
Requirements
- 3-5 years of QA Experience in a Pharmaceutical setting
- BS degree in a relevant field of study from an accredited institution.
- Knowledge of pharmaceuticals, manufacturing, utility, lab systems, and equipment, preferably in solid or semisolid dosage forms.
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical design/commission/validate processes and how they relate to regulatory requirements and cGMP regulations with the U.S. FDA.
- Knowledge of SAP Systems
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