- Person in Plant for Manufacturing runs.
- Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
- Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
- Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
- Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
- Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
- Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
- Write and revise SOP, forms, WI, and any other document types
- ssist with internal and external audits.
- Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
- ssume additional responsibilities as assigned.
- Bachelor's and/or 8+ years of relevant experience
- Minimum 5 years of experience in Quality Assurance
- Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
- Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
- Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
- Excellent communications skills both written and verbal.
- Effective time management and organizational skills.
- Strong attention to details and ability to lead others in a team setting.
- bility to gown and enter clean rooms
- Perform review of Batch records and associated documents in support of the release of a product.
- Review of Analytical data
- Perform QA presence on the floor/person in the plant
- Ensure that documentation and operations meet established requirements of cGMPs, Internal
- SOPs, and company policies.
- Draft and revise procedures as required.
- Performs work that requires decision-making and the consistent exercise of independent judgment and discretion
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