Role: Senior Research Associate
Experience: 3-7 years experience industry experience.
- Primary responsibility is to review preclinical (In vivo & In vitro) reports of all clients and check their relevant compliance with client requirements, regulatory guidelines, and in-house standard operating procedures and generate audit reports for the same and also participate in the discussions in case of any client queries.
- Primary responsibility is to do facility, system and process audits and review related documents both soft and hard copies and ensure their compliance with client and regulatory requirements.
- Review Electronic Laboratory notebooks (eLNB) and ensure their compliance with regulations and ensure implementation of ALCOA+ principles.
- To prepare and review protocols, and in-house standard operating procedures and maintain a schedule of revision dates and if any updates from global standard practices are to be included in a timely manner and uploaded into the electronic data management system (EDMS).
- To review Liquid chromatography-mass spectrometry (LC-MS/MS) calibrations and validations and also check the audit trails of the specific studies.
- Plan and conduct live audit/in-process, retrospective audit, safety audit & Laboratory audits.
- Prepare template checklists for checking the reports and harmonize the report template format as per client requirements.
- To manage the test compounds received from various clients.
- To train the team about quality aspects and update about the regulatory guidelines, and client requirements.
- Strong communication skills.
- Capable of working independently and with a team.
- Innovative and creative.
- Capable of handling pressure & work with pace.
- Enthusiastic to face new challenges.
Interested candidates with desired qualifications, please share your CV at [email protected]