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QA Associate, Quality Compliance (Generic Pharma)
Smart Media
- United States
- United States
About
Company Overview:
Granules Consumer Health LLC is a subsidiary of Granules India LTD, a vertically integrated pharmaceutical company based in Hyderabad, India, with offices in Manassa, Virginia. The company serves as Granules front-end division for private label over-the-counter (OTC) products in the US. With 106 employees and annual revenue of $76.64 million, it focuses on manufacturing, regulatory compliance, and customer service. Key Responsibilities Responsible for incoming inspection of bulk, packaging components, packaged finished product and outgoing product. Perform In-process Quality Assurance job functions and support to the packaging operations. Track controlled documents through issuance of document control numbers, logbooks, change requests, and document status reports. Responsible for periodic review of logbooks issued at the facility. Archive and maintain hardcopy and electronic copies of batch records files, audit files, label files and change history files. Manage all document control logbooks and spreadsheets. Assist in scanning of documents as needed. Provide new hire training on GMPs, Safety, and Pharmacovigilance and maintain the training program documentation. Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures. Perform floor audits for facility as per the SOP requirements. Collaborate with team members to ensure timely deliverables for documentation. Ensure all documents are up to date with respect to version control and issuance. Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls and complaints. Maintain cGMP compliance of the facility. Carry out any other activity as assigned by the supervisor.
Minimum Skills & Qualifications
Bachelor's degree. At least 2 years of QA experience in pharmaceutical or related industry. Experience working with Quality Management Systems.
Seniority Level
Entry level Employment Type
Full-time Job Function
Quality Assurance Industries
Software Development #J-18808-Ljbffr
Languages
- English
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