Cipla Hiring Team Member – M Pharma Candidates Apply
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Job Title: Team Member – QBD Analytical (75701)
Division IPD
Department IPD
Employment Type Permanent
Education Qualification
M. Pharm in Pharmaceutics
Relevant Work Experience
At least 5 years of experience in Formulation Development with exposure to different dosage forms and regulatory requirements
Competencies/Skills
- Communication Skills (clarity of thought, comprehension)
- Likely potential for growth
- Job / Product / Technical Knowledge / Pharma domain knowledge
- Presentation & Interpersonal skills (If applicable)
- Managerial or People Management skills
- Safety awareness (If applicable)
- Relevance of Previous Experience
- Comprehension, Analytical & Problem solving abilities
- Productivity & Result Orientation (If applicable)
- Attitude
- Qualification fitment
- Sales drive (If applicable)
- Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
Job Purpose
Apply QbD principles & techniques during analytical development of both formulations and API to ensure robust high quality product that consistently delivers the intended performance
Accountabilities
I. Implement QbD principles at various stages of analytical
development of formulations and API; prepare action plan for risk identification, risk assessment; and propose risk mitigation & control strategy, in line with regulatory requirements, within the stage gate timelines through brain storming sessions with stakeholders, to ensure robust quality of products and processesII. Identify factors and levels for DOE and select the design; analyse data for finding out the design space within the QbD framework for optimization of analytical development and process
III. Provide inputs on regulatory deficiency queries on the aspects related to QbD or DoE so that satisfactory deficiency response is provided to regulators within timeline
IV. Assist cross-functional teams in addressing risk issues, if any, in commercial batches so that quality standards are maintained during the manufacturing process
V. Review of QbD documents for products developed and/or manufactured through third party to ensure robustness of quality during development and manufacturing
VI. Develop all QbD documents for risk identification, assessment, and mitigation and suggest control strategy for leverage products
VII. Provide training on QbD and DoE to cross functional departments in IPD, DQA, and manufacturing units, to build awareness and knowledge of QbD principles essential to develop quality and robust product performance
Apply Online
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