Executive - QA

Job Description

• Compliance to the instructions given in Batch records of various products.
• Ensuring the compliance of the SOPs and cGMP requirements at shop floor.
• Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process.
• Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance.
• “Sampling” at different stage of manufacturing or as per the requirement.
• Stage wise review of batch records and compliances if any, to facilitate timely release.
• Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.
• Review of master batch manufacturing record and batch packing record in SAP
• Active participation in execution of Qualification and calibration activity.
• Periodic review and preparation of APQR.
• Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS.
• Co-ordination & execution of Self Inspection and compilation of self-inspection observations.
• Active participation in investigation related to product / system failure.
• Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.
• Active Participation in Batch Release Activity.
• Handling eDMS activities.
• Active participations in all the IPQA activities.
• Work Experience

6-9 years

Education

Graduation in Pharmacy

• Competencies