Objective: Deliver analytical services to various global R&D sites, focusing on compliance under the supervision of the J&J analytical team leader or designee.
Key Responsibilities:
- Project Management:
- Deliver project activities within timelines, ensuring quality and safety compliance.
- Analytical Execution:
- Perform physicochemical and instrumental analyses.
- Execute experiments and projects with precision and attention to detail.
- Analyze data, evaluate results, form conclusions, and implement improvements.
- Innovation and Adaptability:
- Design studies and experiments demonstrating creativity and resourcefulness.
- Adjust to changing priorities and project critical paths.
- Continuous Improvement:
- Implement continuous improvements within areas of responsibility.
- Participate in and execute technology transfer and development in the laboratory.
- Compliance and Validation:
- Perform computer system validation (CSV) activities per J&J procedures and guidelines.
- Initiate and coordinate Quality Issues (QI) and Change Controls.
- Implement corrective and preventive actions from audits.
- Generate and maintain raw data/records as required.
- Documentation and Support:
- Prepare Stability Protocols, Reports, SOPs, Work Instructions, and other quality documents.
- Support internal/external audits.
- Collect and share data with external contract laboratories.
- Regulatory Adherence:
- Follow cGMP, pharmaceutical regulations, and compendial requirements in the laboratory.
- Cooperate efficiently with external and internal partners.
- Implement Leadership imperatives for customer satisfaction, innovation, collaboration, and organization.
Functional Competencies:
- Technical Knowledge:
- Proficient in UPLC/HPLC, GC, XRD, Dissolution, Coulometer, PSD, NIR, LIMS, and ELN platforms.
- Expertise in chemistry, analytical techniques, stability study assessment, and research technologies.
- Planning and Execution:
- Ability to plan and execute analytical assignments.
- Identify gaps, root causes, and develop solutions for analytical issues.
- Regulatory and Quality Systems:
- Adequate knowledge of cGMP, quality systems, data integrity, SOPs, and global regulations.
- Technical skills for interpreting analytical data and documenting laboratory investigations and non-conformances.
Qualifications:
- Experience: 5 to 10 years
- Education: Minimum MSc, B Pharm, M. Pharm
- Skills: Good computer proficiency (MS Office)
Critical Personality Attributes:
- Strong verbal and written communication skills.
- Strong analytical and conceptual capabilities.
- Good interpersonal skills and clarity in communication.
- Proven ability to quickly learn new skills and adapt to new processes.
- Ability to work effectively in a dynamic environment with competing projects and deadlines.
Primary Location:
- Asia Pacific-India-Delhi-Delhi
- Other Locations: Asia Pacific-India-Maharashtra-Greater Mumbai