E&l Scientist

2 days ago

Chennai, India Pfizer Full time

Why Patients Need You

Role title: Scientist
- E&L

Role Description Design and execution of E&L studies, Impurity identification and Q3D studies

**Responsibilities**:

- Responsible for

1) Method development, feasibility studies

2) Validation/Scientific protocol preparation and execution

3) Development/Scientific/Validation report preparation

4) Maintaining the laboratory chemical and standards

5) Maintain the lab as per 5S requirements

6) Working with instrumentation team & Validation team for instruments calibration and qualification of new equipment's 7) Coordinating with third party labs for projects handling at external lab

8) Involving in technical assessments for new equipment's

9) Initiation and closure of gQTS records as per the timelines

10) Maintaining the P2L trainings NLT 95%

11) Sound scientific in E&L area as per the regulatory requirement

12) Ensuring the data integrity all the time

13) SOP preparation

Qualification

1) M.Sc./Ph.D. in Chemistry, M. Pharma having more than 5 years of experience

Skill set Required to perform the role.

1) Must have the scientific knowledge in the area of extractables and Leachable

2) Need to be updated on regulatory guidelines

3) Technically sound and good hands-on experience in various mass spectrometric techniques like LCMS, GCMS, ICPMS, TOC

4) Should have experience on Impurity Identification using Mass spectrometry

5) Must possess good Analytical troubleshooting skills and logical thinking skills and data interpretation

6) Should have 5 years of experience with M.Sc./M. Pharma

7) Should have 2-3 years of experience with Ph.D.

8) Should have knowledge and better understanding on GMP and Data integrity

Proficiency level of the skill set: Moderate

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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