Executive - QA
Lupin Chungthang, Sikkim, India
Pharmaceutical Manufacturing · 10,001+ employees
About the role
The role involves ensuring compliance with cGMP and SOPs on the shop floor, including line clearance, in-process checks, and batch record reviews. The executive will also manage quality systems such as CAPA, deviations, and validation activities to facilitate timely product release.
What they look for
Requirements
Candidates must have 6-9 years of relevant work experience in a quality assurance role within a manufacturing environment. A graduation degree in Pharmacy is required for this position.
Full description
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
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