Walk-in for Stelis Biopharma Pvt Ltd on 22-30/8/2017

Job Posted on Aug 21, 2017
Job Type:Walk-in
Company Name:Stelis Biopharma Pvt Ltd
Venue:Plant- Stelis Biopharma Pvt Ltd. (A Strides Enterprise),
Plot No.2-D1, Obadenahalli, Doddaballapur 3rd Phase Bangalore Rural, Karnataka 560105
India
Contact Person:Kiran Kumar S
Phone:9900922668
Email:kirankumar.s@stelis.com
Required in:Formulation Unit
Job Department(s):Quality Assurance
Job Details:• Maintain data integrity in all Activities at Site and ensure appropriate and adequate traceability.
• Extensive knowledge and understanding of Global GMP compliance regulations and industry practices related to Biotech industry.
• Should have sound experience in the Sterile Formulations, BFS, Cartridge filling lines, Lyophilisation and Vial filling lines.
• Hands on experience in implementing quality systems in a GxP environment, and having direct experience with Global health authority inspections preferably USFDA, MHRA, TGA and WHO.
• Should have handling experience in aseptic areas.
• Handling experience in Deviation, OOS/OOT, Market Complaints, Product Recalls, CAPAs, Change Controls, Returned Goods and other quality system documents (eg: PQR) as appropriate; and actively participate in investigations
• Should be familiar with Media fill / APS activities and should have experience in handling of media fill failure investigations.
• Ensure that Quality Objectives are set by management for measuring the performance of the QMS and that these are regularly reviewed as a part of Monthly Quality Review Meeting (MQRM).
• Coordinate and follow up for timely approval and closure of QMS elements like but not limited to Market Complaints, Deviations, Change Controls and CAPA
• Active participation in all regulatory, customer and third party audits and compliance to the audit observations if any.
• Identification of the Document needs and setup the documents for the Product specific suite.
• Preparation of QMS related documents and should impart training to the operators at Shop floor.
• Preparation / Review of Validation documents (PV, CV, Changeovers) and execution of the validation package.
• Extensive knowledge and understanding of Global GxP compliance regulations and industry practices.
• Provide training to users on QMS and regulatory requirements and maintain proactive approach to ensure state of compliance.
• Develop, Implement, control, and upgrade Procedures and systems to ensure that GMP Quality Systems are complied with from Project to commercial manufacturing activities of Drug product
• Preparation of SOPs and procedures ensuring compliance of quality operations at Stelis IN ORDER TO ensure regulatory approvals, compliance to current and changing GMP requirements and contribute to competitive compliance.
• Co-ordinating with all departments to support in Media fill studies for filling lines.
• Adhere to laid down QMS covering all areas from product design to technology transfer in the formulation development areas / control of pilot area activities including batch releases for clinical trials / Pivotal studies.
• Review of routine GMP documentation activities (e.g. batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicators are met the targeted metrics.
• Review of Batch records, Log books, testing records as per laid down procedures.
• Actively participate in periodic review of key quality system procedures at site and implement improvements.
• Implementation of laid down QMS and reduction in non-conformances. Timely completion of CAPA.
Regulatory Exposure:Required
Audit Experience:USFDA, MHRA, TGA, MCC, EMA, UNCST, ANVISA, WHO, HC
Experience:4-7 years
Vacancies:3
Salary Per Annum:Optional
Interview Date:22-30 Aug 2017





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