Quality and Compliance Specialist

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs & Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : Job Title: Quality and Compliance Specialist Job Description Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality & Compliance Specialist (QA) to join our Quality Assurance (QA) team. This Quality Compliance Specialist opening will have an emphasis on supporting the manufacturing operations of our 24x7 facility. The Specialist will directly support the implementation, execution, and maintenance of Quality Systems related to manufacturing to ensure the PPS-Riverview site complies with regulatory requirements as propagated by the United States Food and Drug Administration (USFDA) and other international regulatory authorities. Principle assignments related to compliance may include material release, review and implementation of new and revised documentation to support PPS-Riverview Quality Systems and operations to meet Good Manufacturing Process (GMP) requirements. The scope of this position will support both clinical and commercial manufacturing, as well as process development, in the Riverview facility. This is a shift-based position; the selected candidate must be willing to work weekends, and holidays as needed on a rotating schedule. KEY RESPONSIBILITIES. Review of batch production records (including analytical test packages, cleaning records, etc.): The incumbent's primary responsibility will be to ensure that batches meet GMP requirements and are manufactured according to approved Standard Operating Procedures (SOP), and appropriate resolution to batches pending approval due to GMP errors and related corrective action investigations. Review in-process batch records, finished product batch records and intermediate analytical records. Release intermediate products, based upon conformance with specifications and completion of associated documents. Operations Support: Actively walk the production areas to promote and ensure current Good Manufacturing Practices are being adhered to. In real time address any corrections or deviations with production staff explaining the impact and how to avoid the error moving forward. Review all batch related data generated by the Production team in real time during the shift, including but not limited to executed batch records, temperature recordings, cleaning records, In-process checks, equipment status tags and logbooks for accuracy, completeness and compliance to data integrity. Administrative Duties: Support QA administrative duties such as; issuing master production records and appropriate labeling to manufacturing, ensuring that the current version is issued. File completed batch production records, testing records, and cleaning records. Support maintenance of document tracking systems. Audits: Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during an audit. Conduct internal audits and housekeeping inspections and walkthrough's of site Quality Systems and related operations to ensure compliance with written procedures. Audits quality system and records, creating documentation as needed. Follow-up as appropriate to ensure corrective action is implemented. During an audit of ASH, participate in the audit to explain ASH's quality systems and operations. The incumbent is expected to represent ASH's systems thoroughly and positively, being receptive to the auditor's comments. Participate in the development of a formal response to audit report as appropriate. Reports/Document Management: This may include support to Annual Product Reviews, Non-Conforming Material Reports, and Investigation Reports. Participate in preparation or review of associated documentation, such as Analytical Methods Validation Reports, Cleaning Validation Reports, and Process Validation Reports. Quality Systems Support: Ensure compliance with internal approved procedures of all generated data. Participate in the implementation of continuous initiatives as they relate to production and quality activities. Provide data and inform #J-18808-Ljbffr Piramal Pharma