Associate Scientist II, R&D-ADL

Baxter

3 - 7 years

6 - 11 Lacs

ahmedabad

Posted:-1 days ago| Platform:

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Skills Required

chemistry interfaces team management problem solving analytical chemistry analytical method transfer matrix lab research hplc analytical method validation product design r research and development api method transfer communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for Analytical Method Transfer activity at Baxter and Non-Baxter Manufacturing sites.
Oversee and lead all activities of assigned team/projects to meet customer needs.
Work according to appropriate standards for quality, ethics, health, safety, environment, protection and information safety as per company policy.
Communicate, address and solve problems within own and broader area of responsibility. Communicate effectively across organizational interfaces.
Oversee and write transfer protocols, transfer reports, lab procedures or process related SOPs. Write scientific documents intended for external partners or for generation of registration documents.
Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team members.
Prepare and revise the specification and Method of analysis for API, FP, Excipient and Packaging materials in close co-ordination with CFTs/Manufacturing site.
Responsibility for review of DMF for specifications and analytical method including method validation for all the tests in API and Excipients and review from suppliers and implementation of declarations (Residual solvents, Elemental impurity, Nitrosamine Impurity etc.) at Baxter.
Responsible for Prepare and Update documents as per the Supplier Notifications Change (SNC) related documents for API, Excipient and Packaging related material and their implementation at Manufacturing site.
Preparation of documents against Compendial changes, based on their assessment from CFTs (F&D, RA, PQ, Product Design team, Plant/CMOs and PMT) and its timely implementation at respective manufacturing Sites.
Serve as subject matter expertise in the areas of analytical chemistry internally and externally as needed.
Responsible for Quality change control procedure, CAPA, NCR, etc in TW8 and maintaining quality matrix.
Collaborate with Baxter external partners to ensure successful execution of analytical testing and study designs.

Skills Required:

- Knowledge of Analytical method validation, method transfer, Pharmacopoeia compliance, cGLP and good documentation practices
- Sound understanding of the analytical techniques and good learning agility
- Writing and computer skills relevant to recording of data as well as generating technical protocols & reports and presentations to communicate with internal and external stake holders
- Coordination and relationship management and ability to work in multicultural environment
- Effective communication skills & team management
- Understanding of the latest quality and regulatory requirement
- Good team player and ability to effectively delegate the responsibility to the team members as per the requirement to ensure timely delivery of projects
- Comfortable in taking autonomous actions and decisions
- Working knowledge of cGLP requirements and basic knowledge of working principles of Cross Functional departments
- Communicates well across functional areas and large groups
- Demonstrates critical thinking skills in problem solving and decision making
- Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
- Has good interpersonal skills and works collaboratively in an effective manner to achieve objectives

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