Unichem Laboratories Released Job Openings On 10-01-2022.Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India’s most respected pharmaceutical companies. It is committed to deliver better health through superior products.
Unichem Laboratories Recruiting B.Pharma,M.Pharma,M.Sc Candidates with 5 – 8 years of Experience for Clinical research Scientist Position.Complete Details for the Clinical research Scientist as follows.
Important Details :
- Location : North Goa, Goa
- No of Vacancies:01
- Details of Salary: NA.
- Opening date for online Application: 10-01-2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- Review of LCMS-MS Bioanalytical method development, validation & BE study sample analysis report.
- Review of relevant SOPs as per current and applicable regulatory guidance.
- To ensure compliance to the bioanalytical method protocol, SOPs and applicable regulatory requirements.
- Check accuracy, completeness of pilot/ pivotal Bioanalytical BE study data & reports.
- Review inhouse SOPs due for revision and make them effective within planned timelines.
- Evaluation & checking of ELISA/ LCMS-MS bioanalytical, pre-clinical study analysis of small / large molecules as per GLP guidelines.
- Prepare audit plan and conduct onsite & retrospective audits for Bio studies to ensure compliance to SOPs, Study Protocol, GCP/GLP and Regulatory Requirements.
- Identification of the root-cause for non-compliance / deviations observed from study data and advice on resolving queries from regulatory perspective.
- Experience of handling BE bioanalytical regulatory queries & deficiency.