Ipqa Officer /Senior Officer

Roles and Responsibilities

• Monitor sampling activities in the validation batches.
• Provide information to the shop floor on the validation requirements.
• Carry out risk assessment and mitigation Plans.
• Validate activities to be done as per the predefined criteria and provide the inputs timely to make the validation successful.
• Report the abnormalities observed during the validation batches sampling in time.
• Support the validation execution in terms of events, deviations & validation report closure.
• Perform Line clearance for start up of the activity of various Stages like dispensing, manufacturing and packaging of drug product.
• Perform in process inspection in the manufacturing and packing of products.
• Perform in process and ensure that in process observation of the data entries of the
  process in batch manufacturing documents.
• Perform the calibration of IPQC instruments and maintain the record of the calibration
• Perform in process quality checks during batch manufacturing and packaging operation.
• Review online manufacturing and packing documents and logbooks.
• Perform continuous process verification of the product & process deviation.
• Collect the In process samples (including process validation samples, Blend uniformity samples and stratified samples) during the manufacturing and Packing process, QC samples for analysis, control samples, stability samples etc.

Desired Candidate Profile

• Candidate should have relevant experience in the pharmaceutical Industry, preferably in Oral Solid Formulations and have regulatory exposure to USFDA/ MHRA/EU/TGA etc.
• Should have excellent verbal & written communication skills.
• Ability to work in dynamic environment.
• Should be assertive, proactive, and self-driven.