Qc Chemist

4 days ago

Taramani Chennai Tamil Nadu, India Cephas Life Sciences Private Limited Full time

**Job Title**:Extractables and Leachable (E&L) Specialist.

**Job Summary**:
As an Extractables and Leachable (E&L) Specialist, you will be responsible for developing and implementing testing strategies to identify, quantify, and assess the risk of extractable and leachable substances from materials used in pharmaceutical, medical device. You will work closely with cross-functional teams to ensure that products meet regulatory standards and are safe for consumer use.

**Key Responsibilities**:

- **E&L Testing and Analysis**:

- Design and conduct extractables and leachables testing programs in accordance with industry standards and regulatory requirements.
- Develop and validate analytical methods for the identification and quantification of extractable and leachable compounds.
- Perform laboratory analysis using techniques such as HPLC, GC-MS, ICP-MS, FTIR, and UV-Vis spectroscopy.
- Ensure that E&L testing protocols comply with regulatory guidelines such as those from the FDA, EMA, ISO, and other relevant authorities.
- Prepare and review documentation required for regulatory submissions, including E&L study reports and risk assessments.
- Analysed and interpret data from E&L studies, identifying potential risks and impact on product safety.

**Qualifications**:

- **Education**: Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences.
- **Experience**: Minimum of 2-5 years of experience in E&L testing or a related field within the pharmaceutical, medical device.

**Skills**:

- Proficiency in analytical techniques and instrumentation.
- Strong understanding of regulatory requirements and industry standards related to E&L.
- Excellent data analysis and interpretation skills.
- Strong written and verbal communication skills.
- Ability to work independently and as part of a team.

**Job Types**: Full-time, Permanent, Fresher

**Education**:

- Master's (preferred)

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

Application Deadline: 30/09/2024

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