UNICURE INDIA LTD
Location
Roorkee | India
Job description
UNICURE INDIA Ltd. Unicure India Limited is a pharmaceutical manufacturing company, which is renowned for its quality standards and efficacy of the products. We are committed to making the world a healthier place through the development, production, and marketing of excellent pharmaceutical products. We strive to achieve this objective by developing innovative products, which suit the needs of the patients globally and are superior in terms of quality, packaging, and stability. We have a range of more than 250 molecules across segments and dosage forms. Our state of the art manufacturing facility has been appreciated and approved globally by various regulatory authorities. We are a WHO-GMP, ISO certified company, Government recognized Ex-port House. 1. Job Summary: The Sr.Officer of Quality Assurance department shall be responsible for all IPQA activities, participation in all qualification activities, Process validation activity, QMS activities and ensure the cGMP, GDP fallowed in the organization. Manage and assign the work to below team members and review the activity performed by them. 2.Job Duties and Responsibilities include, but are not limited to: Activities: Ø To ensure the checking of cleanliness and Environmental conditions in Manufacturing , Packing & Warehouse Area. Ø To ensure the checking SOP compliance on shop floor. Ø To ensure the checking of Line clearance activity in Manufacturing, Packing & Warehouse Area. Ø To ensure the Quarantine Activity. Ø To ensure the Balance verification daily and calibration monthly. Ø To ensure the In-Process checks during different stage of Manufacturing ,Packing & warehouse activity. Ø To ensure the samples (Swab/Rinse, & process samples, Hold time Study Sample, Control Sample, Stability sample submit to respective department. Ø To ensure the Process Validation Sample as per sampling plans from different stages and different location of process. Ø To ensure the online filling of log books & BMR & BPR and records. Ø To ensure the AQL at the compression. Ø Responsible for all QMS activity on shop floor i.e Deviation, Incidents, CAPA , Change control at site. Ø Responsible for Batch Manufacturing Record, Batch Packing Record Reviewing & after completion submitted to QA Documentation Cell. Ø Responsible for review & Prepared of departmental standard operating procedures. Ø Responsible for review of Preventive Maintenance schedule, calibration schedules for plant equipment/instruments. Ø To other work assigned by HOD. 3.Other Competencies/Abilities/Skills Required Ø Manage the junior level people for training and execution. Ø Must be familiar with cGMP and Pharmacopoeial Guidelines.
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