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Officer Quality Assurance

Abbott · Baddi

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Collected role description

<p>Followings will be the responsibilities of the position holder:</p><p> </p><p>1. Compliance of current Good Manufacturing Practices in the Oral dosage facility & to follow GDP with data-integrity compliance.</p><br /><p>2. Manufacturing and Packing process compliance in accordance with approved BMR/BPR.</p><br /><p>3. To carry out line clearance, In-process checks at the different stages of batch manufacturing and packing.</p><br /><p>4. Collection and management of control samples / stability samples / validation samples / other samples (as applicable) and maintain their record.</p><br /><p>5. Issuance of Batch records and review of executed batch documents.</p><ul><li>undefined</li></ul><p>6. Issuance of controlled copies of Logbooks and formats.</p><br /><p>7. Compliance of IPQA related SOPs and records.</p><br /><p>8. Calibration of IPQA instruments and to maintain related records.</p><br /><p>9. To assist investigation activities.</p><br /><p>10. SOP training in ISOtrain of self-train within stipulated time.</p><ul><li>undefined</li></ul><p>11. To follow all the practices related to safety and COBC.</p><p> </p><p> </p><p>In absence of the position holder, designated Executive-IPQA shall be authorized designee and responsible for day to day working.</p>