Quality Assurance Associate

7 days ago

Kanchipuram India Endo Full time

Job Description Job Description Summary Responsible for to adherence of cGMP in all activities performed and responsible for compliance. Responsible for planning and Execution of Shopfloor IPQA activities. Responsible for Inporcess Quality Assurance, Responsible for Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ). Job Description - Align to mission, vision & values of the organization and coaching quality assurance team to develop & sustain behaviors that are consistent with PAR HEALTH values. - Responsible for planning and Execution of Shopfloor IPQA activities. Responsible for Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ). - Responsible for Conducting quality examination in regular intervals by performing in-process checks during the production process. - Responsible to perform Sampling of intermediates finished drug products, Reserve samples & stability samples from manufacturing and Packing stages and submission to Quality Control unit for testing. - Responsible for Involvement in hold time study program by performing the sampling and retaining the required sample in controlled storage. Submission of sample to quality control lab on regular intervals as per sampling plan. - Responsible for ensuring the compliance and performing calibration of IPQC-Instrument. - Responsible for to follow the procedures pertaining to the environmental management system and review of EMS alarm history, e-sign with appropriate comments. Report any observation/non-conformance related to the environment management system. - Responsible for Acknowledgement of Maintenance request and performing the impact assessment before closure. - Responsible for performing visual inspection, destruction of reserve sample and Maintenance of reserve sample room. - Responsible for performing product inspection for physical defects as defects as defined frequency in batch record and ensuring the compliance. - Responsible for review batch records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. Responsible for release the bulk, Posting sample quantity and other QA associated transaction in SAP. - Responsible for approving or rejecting all procedures impacting on the identity, strength, quality, and purity of the drug product. Responsible for follow the written procedure applicable to job description. - Responsible for to adherence of cGMP in all activities performed and responsible for compliance.

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