Position Purpose :
Plan and perform scientific/developmental experiments or GMP testing or develop manufacturing processes for the preparation and timely delivery of drug products (DP), processes and procedures; contribute to maintenance of equipment/infrastructure in lab or pilot plant.
1. Plan, organize, perform and document scientific experiments/GMP testing/manufacturing process development activities under moderate supervision; - Take over responsibility for and utilize special tools/equipment or specialized facilities under moderate supervision; schedule and perform maintenance and qualification of instruments/equipment - Keep record of chemicals, intermediates, excipients, standards or consumables
2. Work according to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines; actively participate in proactive compliance and continuous improvement.
3. Provide documentation of raw data, evaluate and interpret results obtained for advanced but established methods or procedures. Review and verify raw data generated by others
4. Write protocols, reports or lab procedures based on templates under moderate supervision
5. Recognize, communicate and provide input to the solution of complex problems (e.g. deviations and unexpected results from experiments); address and solve problems within own area of responsibility.
6. For technical development units: Contribute to development of new methods or optimize existing methods (lab or plant); Contribute to the evaluation of new lab equipment. For GMP units: ensure compliance to cGMP
7. For technology-focused role: Perform information searches under moderate guidance. Actively participate in knowledge exchange. Train and coach technicians, temporary employees and employees under training/education.
8. Support non-project activities as needed, such as Op Ex, GDP coordinator etc.
1. Successful execution of assigned tasks within given timelines at expected quality; right the first time & on time
2. Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines
3. Refer to annual individual and team objective setting
Master or Bachelor of Science or Apprenticeship in industry (or equivalent technical education) with 3 years relevant experience in industry or equivalent Advanced knowledge of English (oral and written). Adequate knowledge in local site-language, as required for the position
• Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
• Adequate theoretical and scientific knowledge in the relevant area (e.g. manufacturing, analytical, pharmaceutical)
• Good practical knowledge of laboratory and/or technical tools.
• Adequate knowledge of software and computer tools.
• Knowledge of current Good Manufacturing Practices (cGMP)
• Good documentation skills
• Basic presentation skills
Qualification : M.Pharm, M.Sc
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : R&D
End Date : 30th November, 2018
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