Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
The objective of this position is to deliver analytical services to various global consumer R&D sites. The position demands a data reviewer/technical writer role to manage the analytical activities with a compliance focus under the supervision of J&J analytical team leader.
Key Deliverables of this role:Preparation of technical documents e.g. stability reports, method transfer and method validation protocol and reports, global change control, procedures, etc.
Review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, LIMS entries, technical reports, etc.
Review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc as required.
Connect with internal groups, global cross functional partners for collating all information and documents required for preparing technical documentation.
Must have functional competenciesExcellent technical writing skills: Drafting, articulation, correctness of language, word/excel/power point formatting and use of appropriate features
Adequate knowledge related to chemistry, analytical techniques, stability study assessment and research technologies
Deep knowledge of GMP, quality systems, SOPs, latest regulatory trends, and global regulations as appropriate and documentation practices
Technical skills related to data review, interpretation of analytical data and accurate documentation of laboratory investigations, NC and CAPA, change control, impact assessments, etc.
Ability to prioritize work and change focus quickly.
Critical Personality Attributes
Ability to connect with cross functions and global partners and collate information.
Attention to detail.
Excellent oral and written communication skills
Systematic approach and commitment to assigned deliverables
About Johnson & Johnson
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