Encube Ethicals is looking to hire Senior Executive-Clinical QA .Interested and eligible candidates can send their resume….Encube Ethicals is an integrated pharmaceutical topical organization dedicated to only semisolid formulations since 19+ years.
Our focus is to consistently excel in manufacturing and development of topical formulations which touches millions of patients globally. For everything that Encube does, we intend to delight Encubians, business partners and end consumers by going beyond their expectations every time………The eligibility criteria as follows.
Vacancy details :
|Company Name||: Encube Ethicals|
|Designation||: Senior Executive-Clinical QA|
|No. of Vacancies :||:NA|
|Salary||: Not Disclosed|
- . Auditing of clinical studies & ensure that the trial is conducted on actual patient as per the approved protocol, GCP and applicable regulatory requirements.
2. Conduct clinical vendor qualification and selection process.
3. Responsible to ensure that clinical study is being conducted in compliance with the protocol, SOPs, GCP, regulatory requirements.
4. Verify that study data is consistent with CRFs and other source documentation (source data verification/review).
5. Independently coordinate ongoing and upcoming auditing assignments.
6. Review of study documents like protocol, SIS & ICF, CRF, COAs & final clinical study report.
7. Identify the need for training in the department and plan training for the team members as and when required.
8. Perform root cause analysis and facilitate the smooth functioning of the departmental activities.
9. Ensure CT documents/BA-BE documents are scientifically correct and meeting the applicable regulatory standards.
10. SOP preparation and / or review.
11. Quality review of drug labels, CT documents and complete CT shipment.
12. To check that all AEs, SAEs are documented and reported properly
How to Apply : Click here for full details and Apply