|Company||Top Pharmaceutical Giant|
|Required Experience||5-7 Years|
|CTC||Best in the Industry|
|Posted On||07 Sep 2021|
|Application Deadline||28 Feb 2022|
GMP, HSE, ISEC guidelines, compliance, continuous improvement, technical writing,
1886! We have more than 130 years of experience treating patients. It is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
Independently plan and perform scientific experiments or GMP testing or develop processes in processes for the preparation and timely delivery of drug substances (DS), various finished dosage forms, processes and procedures for elemental impurities according to health authority requirements; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• Independently plan, organize, perform and document scientific experiments/GMP testing/plant activities under minimal supervision; handle several activities at a time
- Take over responsibility for and utilize special tools/equipment or specialized facilities as an expert; schedule and perform maintenance and qualification of instruments/equipment.
- Proactively identify conflict situations and contribute with empathy to solutions
• Work according to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines; lead initiatives to ensure proactive compliance and continuous improvement.
• Provide documentation of raw data, evaluate and interpret results; propose and provide input for the design of next experiments. Review and verify raw data generated by others; approval of test/experiments performed by others.
• Write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision.
• Recognize, communicate, address and solve problems (e.g. deviations and unexpected results from experiments) within own and broader area of responsibility; actively transfer know-how or procedures to other departments or external contractors, including troubleshooting and on-site training.
• For technical development units: Develop new methods or optimize existing methods (lab or plant);contribute to development and implementation of new technologies.
For GMP units: ensure compliance to cGMP.
• For technology-focused role: Perform information and literature searches under minimal guidance. Actively foster knowledge exchange. Train and coach associate scientists, technicians, temporary employees and employees under training/education.
• For project-focused role: Participate in function-specific sub teams and fulfill assigned project tasks and responsibilities under supervision. Support non-project activities as needed, such as Op Ex, GDP coordinator etc. Minimum requirements
WHAT YOU’LL BRING TO THE ROLE:
• Master of Science with atleast 5 year of relevant experience. Fluent in English (oral and written) Basic skills in local site-language, as required for the position .
• Hands on experience on Elemental impurities method development, validation and technology transfer by using different instrument techniques like ICP-MS, ICP-OES, AAS, XRF etc.
• Interpretation of ICHQ3D requirements & knowledge on various regulatory bodies requirements on elemental impurities.
• Deformulation experience in quantifying excipients by using various analytical techniques.
• Process identification through deformulation with various analytical tools.
• Experience on other characterization techniques like LC-MS, GCMS, NMR, FTIR etc... will be an added advantage.
• Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
• Good theoretical and scientific knowledge in the relevant area (e.g. manufacturing, analytical, pharmaceutical).Proficient with laboratory and/or technical tools.Good knowledge of software and computer tools.
• Good documentation skills and Knowledge of current Good Manufacturing Practices (cGMP)
• Presentation skills and Advanced scientific/technical writing skills