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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