Job Summary

Responsible for the enforcing GMP on the shop floor through overseeing the adherence to standard operating procedures.

Key responsibilities

• To perform daily IPQA checks and controls during manufacturing and packing
• To give line clearance to each stage of manufacturing and packing when all parameters comply as per specifications.
• To ensure compliance of GMP at the shop floor
• To perform daily checks and verification of balances calibration of shop floor and IPQA equipment
• Environmental monitoring in all production shop floor
• Collect, record, retain stability samples and submit to QC.
• Ensure proper reconciliation of the product and packaging materials.
• To immediately record and report deviations/ non-conformance in production area to the QA supervisor
• To record in real time – results and data in respective BMR/BPRS and complete reports and other relevant documentation
• To adhere and comply to; all cGMP and GDocP records/data standards, ALCOA principles, and the company code of conduct for data integrity Any other duties that may be assigned from time to time

Requirements

Skills and Attributes

• Knowledge of IPQA and activities in dispensing, production and packing
• Integrity data verification and completion
• Self-driven and ability to work with minimal supervision
• Attention to detail
• Computer Literacy i.e. Ms. Word, Excel, PowerPoint, Access etc.

Qualifications

• Minimum Diploma in Pharmacy, Chemistry or related field
• Minimum three (3) years’ experience in in-process or operations quality assurance in a pharmaceutical manufacturing industry