QA CRO Posts for Pharma Candidates @ Lambda Therapeutic Research

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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

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