Associate Scientist - Delhi, Delhi, India - Johnson & Johnson
Description
Position Title:
Associate Scientist - Mumbai (Mulund)
The objective of this position is to deliver analytical services to various global R&D sites.
The position demands an analyst role to manage the analytical activities with a compliance focus under the supervision of J&J analytical team leader or designee.
Key responsibilities:
- To deliver the project activities within timelines considering compliance to quality and safety.
- Responsible for
executing the analysis regarding the physicochemical and instrumental analysis. - To execute experiments/projects with a high degree of precision and attention to detail. Analyze data, evaluate results, form conclusions, and implement improvements.
- Demonstrate ingenuity, creativity, and resourcefulness in design of studies and experiments.
- Ensure activities are consistent with project critical path and respond appropriately to changing priorities.
- Responsible for
continuous improvements within area of responsibilities. - Flexibility to work in any project/ team as per the business requirement.
- To participate and execute
technology transfer and development under laboratory. - To execute
computer system validation (CSV) activities as per J&J procedures and current guidelines. - To initiate and coordinate for
Quality Issues (QI) and Change Controls . - To implement
corrective and preventive actions resulting from internal audit/ regulatory audit. - To generate and maintain raw data/ records as per applicable procedures.
Preparation of Stability Protocols, Reports, SOP, Work Instructions, and other quality documents as required.
- Responsible for supporting
Internal/External audits. - Collect and share the data with the
external contract laboratories for the projects handled within group. - Follow
cGMP and implement
current pharmaceutical regulations and
compendial requirement in the laboratory. - Cooperate efficiently with the external and internal partners.
- Practice and implement Leadership imperatives for customer satisfaction, innovation, collaboration, organization.
Functional competencies:
- Working knowledge of
UPLC/ HPLC, GC, XRD, Dissolution, Coulometer, PSD, NIR, LIMS & ELN platforms. - Technical expertise related to chemistry, analytical techniques, stability study assessment and research technologies.
- Ability to plan and execute analytical assignments.
- Knowledge of analytical techniques and ability to identify gaps, root causes of issues and think out of the box to develop a solution.
- Adequate knowledge of cGMP, quality systems, data integrity, SOPs, and global regulations as appropriate
- Technical skills related to interpretation of analytical data and accurate documentation of laboratory investigations and nonconformances.
Qualifications:
Minimum Qualification for the position:
- Experience: 5 to 10 years
- Education: Minimum MSc, B Pharm, M. Pharm
- Other Skills: Good computer proficiency (MS office)
- Critical Personality Attributes:
- Good verbal and written communication skills.
- Good computer proficiency (MS office)
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
- Proven ability to learn new skills quickly and adapt to new processes smoothly.
- Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
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