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| Job Ref. ID: |
50587 |
| Job Title: |
Senior Research Analyst I |
| Division: |
Research & Development |
| Country: |
UNITED ARAB EMIRATES |
| Work Location: |
UAE (RAK head office) |
| Job Type: |
Senior Research Analyst 1 |
| Employment Type: |
Full Time Employment (Limited Contract) |
| Job Description: |
| Purpose: |
To adhere with the GLP principles and to maintain them in an effective manner. Responsible for Method development, method validation or stability related activities. |
| Key responsibilities & Accountability: |
• Designing, planning the development and validation of bioanalytical test methods for the existing and new biotechnology products.
• Support for the production in-process analytical methods verification & qualifications.
• Review of analytical experimental data, compile and report preparation.
• Analytical test method transfer to QC and support for troubleshooting any technical issues.
• Maintain quality records/documents as directed by the department standard operating procedure.
• Preparation of Standard test methods, validation reports, validation protocols, COAs and standard operating procedures.
• Regulatory support for the existing biotechnology products, reviewing new dossiers and preparing feasibility reports for the technology transfer of new products.
• Timely execution of CAPAs and change controls.
• Ensuring compliance with all safety, health and environmental rules, procedure and regulations as it pertains to the lab function.
• Provide training to the new analyst in different type of analytical instruments and analyst qualification to perform the activities in the lab.
• Should be able to lead a team of scientists in daily work flow.
• Provide requirements of equipment, instrument and / or reagent required for new Test Methods.
• Review of external and internal dossiers, CAPAs and interdepartmental activities
• Carrying out feasibility studies to develop method with low cost concept.
• Maintaining the equipment in working conditions and arrange calibration when required. Support Registration department with related requirements for Method and Validation documents.
• Maintaining Analytical records and availability of chemicals, glassware and reference standards (working Primary Standards) with COA.
• Writing protocol and plan for New Stability Indicating Test Method Development & Validation Provide requirements of equipment, instrument and / or reagent required. Take part of stability study
• Take part of equipment qualification activities
• Post registration and Tender support to fulfill the regulatory requirements
• Carrying out feasibility studies to develop method with low cost concept.
• Take part in Technical Package compilation.
• Take part in writing SOP's for equipment, cleaning and calibration to comply with cGMP & GLP. Take part in GLP training.
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| Qualifications: |
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- Education |
Bachelor's or Master's Degree in Biotechnology |
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- Experience: |
• At least 5-10 years' experience in the Product-Development/ Biotechnology based Research and Development in a Pharmaceutical/Drug-Discovery application.
• Must have basic experience in core-techniques related to Cell-Culture, ELISA, Microbiology &/or Biological Potency assays
• Fluent in oral and written English communication
• Should be Proactive in approach, having a solution-centric mind to explore different scenarios and suggest resolution wherever applicable
• Should be a Team player with good interpersonal skill and collaborative skills
• Can work independently with less supervision
• Should practice advance knowledge of the related field and always be in the forefront in implementing Best Practices from Industry
• Accountable and high on ownership, should set priorities to manage and achieve timeline
• Skilled in Scientific Methodology - Using scientific techniques and methods to solve problems.
• Knowledgeable of Excel, Word, Power-point, basic statistics, and their applications.
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- Training: |
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| Key Competencies: |
• In terms of competency you are highly result oriented with strong sense of accountability & ownership
• Excellent interpersonal and intrapersonal skills
• Self-starter with ability to adjust schedules in order to meet commitments
• Excellent in Result & Process Orientation for department achievement
• Responsible in approach with strong analytical skills
• Strong attention to details, high on Accountability & Ownership
• Excellent team building, strong time and task management
• Excellent command in English.
• Highly disciplined, motivated and organized
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| Technical Competencies: |
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