Job Title: Executive - Manufactruing
Roles and Responsibilites
1.
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Responsible for In-process production related activities in DP manufacturing, filling, and packing sections
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2.
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Preparation of batch manufacturing records, process validation protocol/report of DP area and its associated records
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3.
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Responsible for calibration and qualification program of equipment of DP area
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4.
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Execution and review of IQ, OQ, PQ of equipments
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5.
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Perform the Qualification/Verification of equipments and compilation of PV documents of the DP Area
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6.
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Handling of Equipments and process related to DP manufacturing, filling, and packing sections
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7.
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To manage the product related activity, in absence of primary responsible person
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8.
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To check and ensure to carry out all the process activities in the plant with compliance of cGMP standards.
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9.
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To ensure safe working conditions, safe operating practices and usage of PPE by all workers and staff.
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10.
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Ensure to identify and resolving engineering issues to keep availability of equipment and utilities as per production planning and thereby ensure zero production loss due to breakdown.
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11.
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Check that all equipments used in area are calibrated, qualified, clean and in good condition for intended use.
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12.
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Ensure to check area, equipment cleanliness & environmental condition before commencement of Manufacturing & packaging of products.
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13.
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Ensure that Manufacturing & Packaging of batches is carried out strictly as per the procedure laid down in respective BPCR/BPR
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14.
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To ensure availability of consumables, and material issue required for the DP area.
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15.
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To ensure proper utilization of resources with high productivity with zero wastage
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16.
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Ensure to maintain all documents required for regulatory compliance are maintained properly. To check online filling of records and submission to QA department.
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Qualification Required
B. Pharm / M. Pharm
Plasma Fractionation Unit, Ahm, GJ, IN, 382210