Job Description :

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 Deliverables of this role:

- To plan the execution of tasks assigned by completing analyses right-first time and within analytical testing window

- To prepare technical documents e.g. method transfer and method validation protocol and reports, etc.

- To perform analysis according to current effective protocol, specifications, analytical methods, and laboratory processes

- To verify trending of results as per established laboratory procedure

- To report results and submit the documentation for data validation in a timely manner, as per established laboratory procedure

- To immediately escalate issues/observations/non-conformance to supervisor as per applicable procedures/policies

- Participate in handling and resolution of laboratory non-conformances with related documentation, perform investigation analysis in timely manner, and provide necessary information

- To ensure trainings are completed on time, and all tasks are performed only after completion of trainings on current effective procedures.

- To provide technical/scientific support to other lab personnel within the premise

- To perform laboratory support activities as per training and perform tasks related to audit readiness

- To participate in project teams as analytical technical team member, as applicable

- To attend (in-house) seminars, scientific meetings in own field

- To attend the department meetings and participate in the initiatives for quality improvement process, as applicable

- To compile data and collate information, such as required for regulatory submission, or preparation of work instructions and standard operating procedures

Must have functional competencies :

- 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 non-conformances

- Adequate articulation and technical writing skills

- Ability to plan and prioritize assigned work

Critical Personality Attributes :

- Ability to grasp processes and lab practices to independently execute basic analytical deliverables

- To stimulate and encourage new ideas and improvement processes

- Good oral and written communication skills

- Systematic approach and commitment to assigned deliverables

- Must be able to work independently with minimum supervision to meet deadlines and maintain a positive attitude

- Good to have some basic understanding of data visualization, statistical trending

Qualification :

Experience: 1 year to 3 years

Education: Minimum MSc, B Pharm, M. Pharm

Other Skills: MS office

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