Associate Director of Quality Control Job

Associate Director of Quality Control is needed to perform the following duties:

• Overall monitoring of quality control activities. Conduct laboratory investigations and evaluations to ensure compliance with SOPs, FDA, DEA, ANDA, and OSHA regulatory guidelines.
• Always maintain the cGMP and GLP practice in Quality control laboratory.
• Write and review investigation reports, proposed CAPAs, deviation, risk analysis, and reports to identify root causes using IQ/OQ/PQ, QMS, Change Control.
• Thorough investigate all lab investigations per regulatory guideline, identity root causes and define proper corrective and preventive action to avoid reoccurrence
• Procurement of lab instruments, accessories, chemicals per project needs. Qualification and Calibration of the Quality control laboratory Instruments and Equipment’s. Coordinate with other departments like QA and production on all QC activities related to raw material, in-process, finished product, and stability testing.
• Review and ensure all laboratory records and documentation are maintained as per cGMP and GLP/GDP guidelines.
• Review and updation of all QC documents per current regulatory guideline. Ensures all QC Laboratory records and documentation are maintained as per cGMP and 21 CFR211.194 guidelines.
• Coordinate and provide the required technical expertise in installation and commissioning of new instrument/equipment in the Quality control laboratory.
• Responsible for improving technical skill of QC analysts by providing training on different topics like analytical technique, good laboratory practices, good documentation practices, Data integrity etc.

Bachelor’s degree in Pharmaceutical Science or Pharmaceutics or Chemistry or Pharmaceutical Engineering OR education + experience which is equivalent to Bachelor’s degree in Pharmaceutical Science or Pharmaceutics or Chemistry or Pharmaceutical Engineering