Job Description

QA Associate, Quality Compliance (Generic Pharma)

Granules Consumer Health LLC, a subsidiary of Granules India LTD, is looking for a QA Associate to support quality compliance for OTC generics in the U.S. This full?time role is located in Manassa, Virginia. We serve as Granules front?end division for private label over?the?counter products. We offer high?quality OTC generics at an affordable cost and are dedicated to excellence in manufacturing, quality, and customer service.

Job Type: Full?time

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 the issuance of Document Control numbers, logbooks, change requests, and document status reports.
• Periodic review of logbooks issued at the facility.
• Archive and maintain hard?copy 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.
• cGMP compliance of the facility.
• Any other activity as assigned by the Supervisor.

Minimum Skills & Qualifications:

• Bachelors 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

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