Job Description Summary
We are seeking a highly motivated analytical R&D chemist to join our research and development team.We require 2 to 5 years’ experience and Post graduate chemistry/Analytical in developing and validating analytical methods for testing of API and release according to ICH and regulatory requirements.
Having through knowledge of GMP operation and ability to work on Wet analysis and analytical instruments HPLC/GC/GCMS/IR/LCMS.
Job Description
To ensure good housekeeping and adhere to GLP/cGMP norms in ARD Lab and maintain cleanliness of instruments and equipment’s.
To support and perform analytical method Development for each project timely.
To support and perform analytical validation/Method transfer for each project timely
To support regulatory requirement as per committed timeline.
To provide analytical support related to production for sorting out issues, yield improvement and further optimizing the process as per schedule.
To Sample/analyze RM,KSM, in process, cleaning, intermediate, stability and API and report preparation
To Analysis and documentation of Reference standard samples as per MTH
To support and perform analytical method development/Validation for EI by ICPMS and,IC,GCMS LCMS timely.
To ensure completion of documents & data integrity and regulatory environment
To support for Calibration/Preventive maintenance of all analytical instruments
Review of all executed analytical documents.
Maintenance for HPLC /GC Columns.
To perform Partial validation, Holding study, DMF queries and physiochemical studies
Responsibility for QMS system like Change control, Deviation and CAPA and related to QMS.
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What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs. Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward. Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life. Endo has global headquarters in Malvern, Pennsylvania. Community Guidelines: 1. Be respectful. Everyone who visits our page should feel comfortable and respected. 2. If we see a comment that violates anything in the following list, it may be removed. • Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional. • Comments that are excessively repetitive and/or disruptive to the community. • Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter. • Comments that appear to be medical advice. We reserve the right to remove a reply for any reason at any time. 3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088. Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.
