Responsible for assisting / performing facility, process, vendor and local validation activities to assure compliance with applicable federal, state, and local regulations as well as corporate policies, Good Manufacturing Practice (GMP), applicable ISO requirements and Standard Operating Procedures (SOP). Responsible for supporting preliminary reviews of local quality requirements from the Quality Management System (QMS). Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management
JOB RESPONSIBILITIES
Ø Prepare, review, and update SOPs, work instructions, protocols, and quality documents to ensure compliance with regulatory and internal standards. Ø Manage the issuance, revision, and distribution of quality documents, ensuring proper version control. Ø Maintain an organized document control system for easy access, traceability, and confidentiality. Ø Periodically review and update documents to reflect changes in regulatory guidelines and internal processes. Ø Provide training on document control procedures to staff and ensure new documents are communicated effectively. Ø Identify and assess risks to product quality, safety, and regulatory compliance using methodologies like FMEA and RPN. Develop and implement risk mitigation strategies to minimize potential risks. Ø Continuously monitor and evaluate the effectiveness of risk mitigation actions, implementing corrective measures when necessary. Ø Document risk assessments, findings, and actions for audit traceability. Ø Lead and participate in the validation of manufacturing processes, systems, and equipment to meet regulatory standards. Ø Ensure all equipment and facilities are qualified according to regulatory and internal guidelines (e.g., IQ, OQ, PQ). Review validation and qualification protocols, reports, and results to ensure compliance. Ø Manage the impact of changes on validated systems, ensuring re-validation is performed as necessary. Ø Review and assess proposed changes for potential impact on product quality and regulatory compliance. Initiate formal change control requests and document impact assessments for approval. Ø Coordinate the implementation of approved changes, ensuring proper validation, qualification, and training. Ø Maintain records of change control activities, ensuring compliance with regulatory and internal standards. Ø Monitor the effectiveness of changes post-implementation to ensure desired outcomes are achieved. Ø Ensure all quality-related documents are clearly written, easy to understand, and aligned with operational procedures and industry standards. Ø Identify, document, and investigate deviations from established procedures and specifications in production or testing. Ø Investigate OOS results, performing root cause analysis and determining their impact on product release. Ø Implement CAPAs to address deviations and OOS issues, ensuring corrective and preventive actions are taken. Ø Document deviation and OOS investigations, including findings, corrective actions, and outcomes. Ø Analyze trends in deviations and OOS results to recommend preventive measures and process improvements. Ø Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory guidelines from agencies such as the FDA, EMA, or other relevant authorities. Ø Conduct internal and external audits to assess compliance with quality systems, manufacturing processes, and regulatory requirements. Ø Ensure that batch records and other documents related to the production process meet all quality and compliance criteria. Ø Prepare and review quality-related reports for management, regulatory bodies, and other stakeholders, ensuring that all findings are communicated clearly and effectively. Ø Investigate and document any deviations from established quality standards, implementing Corrective and Preventive Actions (CAPA) as necessary. Ø Ensure that all products are released according to established quality and regulatory standards. Review the results of quality tests and ensure the product is safe for use or sale. Ø Review and investigate customer complaints related to product quality, supporting the investigation process to identify root causes and corrective actions. Ø Evaluate and qualify suppliers for raw materials, components, and services, ensuring they meet the necessary quality standards. Ø Conduct periodic reviews and audits of suppliers to assess their continued compliance with quality expectations and standards. Ø Collaborate with cross-functional teams to improve manufacturing processes, quality systems, and operational efficiency. Ø Use tools like Lean or Six Sigma methodologies to reduce waste, optimize processes, and improve quality metrics. Ø Provide training and guidance to new and existing employees on quality standards and regulatory compliance. Ø Continuously monitor and update knowledge of pharmaceutical regulations, guidelines, and industry best practices. Ø Assist in the preparation of regulatory documents and filings, ensuring that all necessary quality data is included. Ø Communicate with regulatory bodies during inspections, audits, or investigations, responding to questions and providing documentation as needed. Ø Evaluate and mitigate potential quality risks in the manufacturing process, ensuring that risks to product quality and patient safety are minimized. Ø Ensure the proper storage, handling, and labeling of raw materials, in-process materials, and finished goods to prevent contamination and ensure traceability. Ø Help maintain the QMS, ensuring that documents, specifications, and standard operating procedures (SOPs) are up-to-date and compliant with regulations. Ø Provide necessary support and input to R&D during product/process development, technology transfer, and new product launches. Ø Works as a member of a team to achieve all outcomes. Ø Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Ø Performs all work in support of our
Values:
Collaboration, Courage, Perseverance, and Passion. Ø All other relevant duties as assigned.
Education :
Bachelor of Science in Pharmacy, Chemistry, Microbiology, or highly related Life Sciences.
Expected hours:
40.0 per week
Benefits:
Dental insurance Health insurance Paid time off Vision insurance
