Posted:6 days ago|
Platform:
On-site
Full Time
Responsibility:
Quality Assurance (QA)
QA focuses on the overall systems and processes to prevent errors and ensure consistent production.
· Documentation Management: Preparing, reviewing, and updating Standard Operating Procedures (SOPs), batch manufacturing records (BMRs), and batch packing records (BPRs).
· Quality Management System (QMS): Implementing and maintaining the QMS to align with standards such as ISO guidelines.
· Audits and Inspections: Planning and conducting internal audits, and preparing for external regulatory inspections (e.g., FDA, EMA).
· Deviation and CAPA Handling: Investigating deviations, out-of-specification (OOS) or out-of-trend (OOT) results, and implementing Corrective and Preventive Actions (CAPAs).
· Change Control: Managing and reviewing proposed changes to processes, materials, or equipment to assess their impact on quality.
Quality Control (QC)
QC focuses on the practical, laboratory-based testing of materials and products to detect any issues.
· Sampling and Testing: Sampling and conducting analysis/testing of incoming raw materials, packaging materials, in-process samples, and finished products.
· Analytical Techniques: Using analytical instruments and techniques such as HPLC, GC, UV-Vis spectroscopy, and microbiological testing.
· Instrument Calibration: Performing calibration and verification of analytical instruments, balances, and other laboratory equipment, and maintaining detailed calibration records.
· Data Analysis: Reviewing and analyzing test data and reports to identify trends and areas for improvement.
· Stability Studies: Preparing stability protocols, conducting stability studies of products, and evaluating the data.
· Documentation: Preparing analytical reports, certificates of analysis (COAs), and ensuring all laboratory records comply with Good Laboratory Practices (GLP).
Job Type: Full-time
Pay: ₹18,000.00 - ₹20,000.00 per month
Benefits:
Education:
Work Location: In person
Virgo Uap Pharma Pvt. Ltd
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