My client ar elooking to recruit 4 contract staff to lead and execute the technical aspects of equipment qualification which encompass project management, qualification related
documents preparation and review, procedures preparation and review, execution
of qualification/validation activities and problem-solving.
Key Responsibilities:
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Manage and lead equipment qualification activities, which includes all ancillary systems such as computer system validation, equipment commissioning and site preparation
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Collaborate with client to ensure all tasks are delivered based on client's quality systems and operational systems
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Write and review qualification related documents which include change control, user requirement specification, functional specification, installation qualification protocol and report, operational qualification protocol and report, performance qualification protocol and report, traceability matrix, operating SOP, calibration and maintenance SOP etc
Competencies:
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Bachelor Degree in Chemistry, Biochemistry, Biotechnology or equivalent
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At least 2 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment
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Demonstrate strong ability to lead and drive project to completion
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Demonstrate strong technical experience e.g. in the area equipment qualification, deviation management and investigation
Technical Skills
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Some knowledge in computer systems validation requirements and approach
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Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
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Knowledge in equipment qualification
Problem solving
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Solves problems and implements corrective actions using six sigma tools
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Presents in a timely manner major issues to the overall project lead (either client or Audentiq) and senior consultant/director with strategies on their resolution.
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Participate as a key member to solve major or critical issues
Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).
