Career at Bilcare Research as Senior Manager Projects and Senior Manager Quality Assurance & Regulatory

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Bilcare Research is an innovation-led solutions provider that partners with the global pharmaceutical and healthcare industry to improve patient healthcare outcomes. We endeavour to deliver effective and affordable solutions that enhance the speed and quality of drug discovery and help build and protect brands by ensuring the delivery of genuine medicines to patients.

Post: Senior Manager Projects & Senior Manager Quality Assurance & Regulatory

Senior Manager Projects
Education: B Pharm / M Pharm

Experience: 12-15 yrs.

Job Role: Should be able to lead a team of Project Managers and well versed with Clinical Trial Industry in terms of Project Management. Shall be able to design/ understand Protocol and assist clients in executing the Project in Time bound , Cost bound manner and executing it flawlessly. Need to work closely with Business Development Team, Internal Team and will have Customer interface and Audit Interface. Should be well versed with GMP, GCP and GWP Shall be responsible for Negotiation of legal Compliance. International exposure is welcome. Should have knowledge of Microsoft Office, Microsoft Projects and SAP.

Senior Manager Quality Assurance & Regulatory
Education: B Pharm / M Pharm / PhD in Science or Pharmacy

Experience: 12 -15 yrs.

Job Role: Overall responsible for Quality Assurance, Quality Control and Regulatory functions. Exposure to Clinical Trial Management, IVRS / IWRS. Responsible for customer audit & regulatory compliance to FDA, International accreditations like USFDA, MHRA, ISO or equivalent. Liasioning with government authorities like FDA, DGCI Office, CBN etc. Support Business Development in the area of Regulatory Services and Consultancy services. Harmonization of Procedures and Practices with other regions of GCS. Responsible for Quality Risk Management and Business Continuity Plan/ Disaster Recovery Plan. Must have knowledge of Validations/ Qualifications. International exposure is welcome. Should have knowledge of Microsoft Office and SAP.

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Last Date: 1st Oct., 2011

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