Lambda Therapeutic Research
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA.
Job Title: Group Leader – QA ,for Lambda CRO – Location – Mahesana
Experience : 2 – 6 Years
Location : Mehsana
Salary: INR 3,00,000 – 6,00,000 P.A.
Job Description:
- Planning and review of clinical BA-BE audit related activities.
- Maintain projects tracking and assignment of project specific and non-project specific work to team.
- Planning and review of clinical Report.
- Review of calibration and validation documents.
- Monthly report preparation.
- Trending of audit observations and escalation of open points and quality concerns to HOD/Management.
- Providing support in sponsor and regulatory inspections and review of sponsor and regulatory observations.
- Review of Clinical Pharmacology and Medical Affairs, Clinical Pharmacy and other cross functional SOPs for correctness, adequacy and completeness.
- Planning and conducting of system audit in CPMA and other assigned department and tracking of system audit responses for closure of audit observations.
- Planning, scheduling and assessment of new joiner auditors for in process audit of study related activities, retrospective audit of raw data, study report audit & other applicable aspects.
- To support QA Auditors in day to day audit activities.
- Conduct audits of vendors who are service providers, to assess compliance to Quality System at their end.
- Review of software validation related documents
- Review of deviation, change control and investigation reports.
- Arrange department discussion meeting to discuss open issue & repetitive observation and assist to HOD for QRB meeting.
Qualifications:
Education:
- UG -B.Pharma – Pharmacy
- PG – M.Pharma – Pharmacy
