Validation Engineer

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    "description_html": "<p>&nbsp;&nbsp;</p><p><strong>Greetings from Kashiv Biosciences!!!!</strong></p><p><br></p><p>We are looking for <strong>Qualification, Validation and QMS Engineer</strong> for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities.</p><p><br></p><p><strong>Roles and Responsibilities</strong></p><ul><li>Responsible for <strong>Engineering compliance, Equipment Qualification, Validation and QMS activity.</strong></li><li>Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions.</li><li>Representing as a <strong>Subject Matter Export of Engineering department</strong> in front of regulatory auditors.</li><li>Responsible for <strong>engineering investigations</strong> pertaining to equipment failures and ensure for proper root cause identification and <strong>CAPA effectiveness</strong>.</li><li>Responsible for <strong>technical agreements with vendors</strong> who have work at Plant premises.</li><li>Responsible for<strong> preparing and review the master list of equipment, instrument along with the preventive maintenance &amp; calibration scheduled</strong>.</li><li>Responsible for <strong>change control/deviation management/CAPA </strong>Through Quality management System.</li><li>Facing the Regulatory, Customer, Internal Audits and preparation of compliance.</li><li>SOPs and Protocols Training for the new personnel and refreshment training for existing team members.</li><li>Co-ordination with CFT line Production, QC &amp; QA department to execute any engineering documentation related works.</li></ul><p>Interested candidate please share the resume on my mail id <strong>[email protected]</strong><br></p>",
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      "description": "<p>Description</p><p>  </p><p><strong>Greetings from Kashiv Biosciences!!!!</strong></p><p><br/></p><p>We are looking for <strong>Qualification, Validation and QMS Engineer</strong> for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities.</p><p><br/></p><p><strong>Roles and Responsibilities</strong></p><ul><li>Responsible for <strong>Engineering compliance, Equipment Qualification, Validation and QMS activity.</strong></li><li>Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions.</li><li>Representing as a <strong>Subject Matter Export of Engineering department</strong> in front of regulatory auditors.</li><li>Responsible for <strong>engineering investigations</strong> pertaining to equipment failures and ensure for proper root cause identification and <strong>CAPA effectiveness</strong>.</li><li>Responsible for <strong>technical agreements with vendors</strong> who have work at Plant premises.</li><li>Responsible for<strong> preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled</strong>.</li><li>Responsible for <strong>change control/deviation management/CAPA </strong>Through Quality management System.</li><li>Facing the Regulatory, Customer, Internal Audits and preparation of compliance.</li><li>SOPs and Protocols Training for the new personnel and refreshment training for existing team members.</li><li>Co-ordination with CFT line Production, QC & QA department to execute any engineering documentation related works.</li></ul><p>Interested candidate please share the resume on my mail id <strong>[email protected]</strong><br/></p><p>Requirements</p><p><br/></p><p><br/></p><p> <u><strong>Candidate Details</strong></u> </p><ul><li><strong>The candidate should be from Pharma industry only having exposure to Drug Substance(Biosimilars)/ Parenteral/ Injectables.</strong></li><li><strong>The Candidate Must have B.Tech/ B.E degree and should be working in Engineering Team. </strong></li><li><strong>The candidate should have minimum 5 Years of experience in handling technical documents.</strong></li><li>The candidate should be aware of <strong>GDP/ GMP Process.</strong></li><li>The candidate should have exposure to <strong>equipment qualification, Validation and QMS</strong>.</li><li>The candidate should have good communication skills.</li></ul>",
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