Quality Assurance Associate

Overview:

• Enforcing the Quality Assurance mechanism of the company as per ICH, cGMP-FDA guidance document/s and In-House SOP’s.
• Developing, updating, and implementing policies and procedures to ensure optimum quality assurance.
• Preparing and reviewing documents like SOP’s, Batch records, Validation Protocols etc.
• Issuing BMR’s; reconciling & timely closing of batch records.
• Planning and enforcing the on-line Quality Assurance checks at each level viz: receiving, dispensing, compounding, packaging, and shipping of products.
• Stability data compilation
• Timely Identifying, documenting, and investigating cGMP related issues, deviations; conducting root cause analysis and making sure timely resolution & completion of all investigations and closing of documents according to cGMP standards & US FDA guidelines
• Support upper management during the External Quality & Regulatory Audits by customers and Governmental agencies and preparing & submitting timely responses to audit observation.
• Conducting internal audits and taking timely corrective actions wherever necessary
• Controlling and Safekeeping the printed labels and issuing the same for commercial production
• Assist the R&D Department in formulating the stability & validation protocols for all new products.
• Assessing, recommending, and formulating Training Sessions at regular intervals for employees of all departments
• Preparing Annul Product Reviews (APR). Submitting reports to upper management
• Arranging Sampling of received raw materials and components and forwarding the same to QC for testing
• Obtaining the QC test results for each received raw materials and components and release of the same when the materials pass QA & QC tests
• Approving and documenting the deviations in production and packaging activities
• Transferring completed Production Batch Records to Regulatory Department at regular intervals
• Checking Equipment calibrations, qualifications & Validation Records.
• Manage the samples log in activities and pulling the stability samples.

Job Type: Full-time

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Massena, NY: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• Quality assurance: 3 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location