30 Jul
|
Advity Research
|
Hyderabad
30 Jul
Advity Research
Hyderabad
Location: Hyderabad
Experience: 04 - 05
Qualifications & Other Specifics
Qualifications:
M.Pharm
Preferred Skills:
Communication skills (Written/Oral).
Attention to details.
Teamwork and collaboration.
Ability to work independently.
BA/BE Process clinical domain knowledge required.
Computer skills (MS-Word & Excel).
Positive analytical skills and proactive thinking.
Detailed Responsibilities:
Conduct of Clinical BA/BE study audits.
Review of PK & Stat data, CDISC data.
Review of draft Protocols, ICD, CRF and Clinical Study report.
Conduct of System and Vendor audits.
Review of clinical draft SOPs.
Facilitating in support for client/regulatory audits.
Review of client audit Reponses.
Provide inputs for client RFI.
Identify the gaps and contribute for QMS improvement.
📌 Qa Auditor Ba/be Hyderabad
🏢 Advity Research
📍 Hyderabad