About this role
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