Location: Sellersville
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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 : www.piramalpharmasolutions.com
Job Title
The Senior Quality Specialist, QMS & Compliance is an experienced individual contributor responsible for the day-to-day execution and continuous improvement of the site audit, supplier qualification and Drug Enforcement Administration (DEA) compliance programs within a pharmaceutical CDMO environment. Reporting to the Senior Manager, Quality Systems & Compliance, the role plans, coordinates, conducts and documents internal audits, customer audits, supplier and service-provider qualification activities, and assigned DEA controlled-substance compliance activities.
The position partners with cross-functional process owners to ensure findings, commitments, corrective actions, qualification decisions and compliance records are accurate, risk-based, timely and inspection-ready. The incumbent exercises independent Quality judgment within delegated authority and promptly escalates significant compliance, product, patient, customer or business risks.
Regulatory and corporate requirements: Adhere to applicable FDA, DEA, EPA, OSHA and other safety, health, environmental and Quality requirements, policies and practices.
Values: Consistently support and demonstrate Piramal Pharma Solutions mission, values and standards of ethical conduct
KEY ACCOUNTABILITIES
Job description provided by Piramal Pharma Limited.
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