Quality and Compliance Specialist

## Quality and Compliance Specialist Apply remote type:
Onsite locations:
Riverviewtime type:
Full time posted on:
Posted Todayjob requisition :
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* * 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  and 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 :(Use the "Apply for this Job" box below). Title Quality and Compliance Specialist

Job Description Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility 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…