Junior Officer

Job Overview

The Junior Officer will be responsible for comprehensive quality assurance activities related to pharmaceutical production processes. This includes sampling, testing, documentation, and compliance verification to ensure adherence to quality standards.

Key Responsibilities

• Perform in-process sampling and testing at various production stages.
• Collect samples of bulk finished products and packed items for quality checks.
• Carry out hold time study executions and sample collections at different hold time intervals for bulk finished and packed products.
• Conduct routine Quality Assurance inspections to identify and document any deviations from established systems and Standard Operating Procedures (SOPs).
• Responsible for maintaining instruments used in In-Process Quality Control (IPQC) and ensuring their calibration is up to date.
• Review and maintain logbooks and records related to environmental monitoring.
• Perform online reviews of multiple records such as equipment usage, cleaning logs, area utilization records, and balance calibration documentation.
• Manage line clearances for varied operations within the Production department to ensure compliance prior to process initiation.
• Execute, review, and approve critical documents including Batch Record Reviews (BRRs) and Electronic Standard Protocols (ESPs) within the PAS-X system.
• Oversee preparation, review, and approval of batch manufacturing and batch packing records.
• Participate in equipment qualification activities as required by compliance and quality standards.
• Conduct cleaning validation and equipment qualification procedures to maintain production quality.
• Fulfill customer requirements concerning samples and documentation prerequisites.

Experience & Education

Candidates should have between 1 to 3 years of relevant work experience. Educational qualifications include a Bachelor's or Master's degree in Pharmacy.