Manager - Quality Assurance (biosimilars) in Navya Biologicals Pvt Ltd

Job Posted on Sep 14, 2017

Company Name:Navya Biologicals Pvt Ltd
Address:NavDisha", STEP Building,
BVBCET, Vidyanagar,
Hubli – 580031,, Karnataka Hubli – 580031,
Contact Person:Miss Parveen
Required in:API Unit
Job Department(s):Quality Control, Quality Assurance, Microbiology, Production, Regulatory Affairs, Research
Job Title:Manager - Quality Assurance (biosimilars)
Qualification:M.Sc, M.Pharm, M.Tech, Ph.D
Job Details:Job Description

• Defines tactical/operational strategy/road map for quality assurance management at Biopharmaceutical R&D and manufacturing sites; defines site quality assurance goals and strategy in line with Company Quality Policy, product quality management objectives and regulatory requirements and Oversee QA operations at the site.
• Ensuring compliance to QA regulatory requirements in manufacturing and for tracking quality assurance metrics e.g. deviation, OOS/OOT, CAPA effectiveness, market complaints with site manufacturing / QC Management and driving them down.
• Responsible for designing, implementing and ensuring compliance to all quality assurance related SOPs at biopharmaceutical manufacturing and R&D sites.
• Facilitate internal and regulatory agency audits, ensuring that findings from Site audits are understood assessed thoroughly. Prepare response for audit observations and ensure closure with in time
• Accountable for designing/implementing at site quality policies, standards & QA systems
Ensuring compliance to all quality related SOPs at site and Review approve/Reject specifications, analytical methods, SOPs, Master Batch Record
Review, Approved/Reject change controls related to manufacturing, QC, QA, Engineering as per SOP
• Ensure availability of adequate Stability management Program / SOP including review to maintain compliance with GMP requirements.
• Monitor industry trends/issues faced internally and identify scope for improving Site QA management and processes.
• Review and update the Audit compliance and presentation to the Top Management.
Design and Manage Vendor Audits, Plant Audits etc.,
• Review and decide activities with respect to BPR, Raw materials, Packaging materials, IQ, OQ, PQ , validations, Lab Instruments and ensure all these are in place with respect to SOPs, Specs etc.,
• Build and manage QA teams on Greenfield manufacturing site in Dharwad

Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Director
Regulatory Exposure:Required
Audit Experience:USFDA, UNCST, ANVISA, WHO
Last Date:15/10/2017
Note:Please send your resume to above email address to apply for this job.

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