QA Associate, Quality Compliance; Generic Pharma

Description

Granules Consumer Health LLC is a subsidiary of Granules India LTD, a vertically integrated pharmaceutical company with headquarters in Hyderabad, India. Granules Consumer Health LLC is located in Manassa, Virginia. We have 106 employees and annual revenue of $76.64 million. We serve as Granules’ front-end division for private label over the counter (OTC) products in the US. We offer OTC generics that meet the highest level of quality at an affordable cost.

As such, we are well-established on bulk supply through efficiencies garnered through manufacturing, integration and a high level of regulatory compliance. We are dedicated to excellence in manufacturing, quality, and customer service.

• 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 the 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 GMP’s, 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.
• Ensuring 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.
• cGMP Compliance of the facility.
• Any other activity as assigned by the Supervisor.

• Bachelor's degree
• At least 2 years of QA experience in pharmaceutical or related industry
• Experience working with Quality Management Systems