Executive QA SK

Job Description

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Compliance to the instructions given in Batch records of various products.

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Ensuring the compliance of the SOPs and cGMP requirements at shop floor.

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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.

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Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance.

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“Sampling” at different stage of manufacturing or as per the requirement.

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Stage wise review of batch records and compliances if any, to facilitate timely release.

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Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.

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Review of master batch manufacturing record and batch packing record in SAP

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Active participation in execution of Qualification and calibration activity.

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Periodic review and preparation of APQR.

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Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS.

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Co-ordination & execution of Self Inspection and compilation of self-inspection observations.

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Active participation in investigation related to product / system failure.

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Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.

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Active Participation in Batch Release Activity.

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Handling eDMS activities.

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Active participations in all the IPQA activities.

Work Experience

6-9 years

Education

Graduation in Pharmacy

Competencies