QA Clinical Trial Job Opening at Intas – Chemistry & Pharma
Intas Pharmaceutical Limited invites undergraduates Pharma candidates for Quality officer post vacancy. Candidates with experience in Pharma filed may apply for this job post via online mode. Check out all the details on Rasayanika.com
Job Title: QA – Clinical Trial
No.of posts: 01
Eligibility: BSc, B Pharma
Experience: 4 – 9 Years
Salary: INR 4,00,000 – 9,00,000 PA. Medical Insurance (self + 3 Family Member)
Job Description:
- To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to all applicable Regulatory requirements, Organizational requirements (Policy, Procedures and processes) and Clients requirements (protocol, contract etc.) by routinely conducting audits (In process, on-site and off-site) at various stages for all assigned projects.
- To perform retrospective audits of study related raw data like Informed Consent Forms, project management plan and associated Plan, IMP plan, IMP release checklists, Safety Management Plan (SMP), Clinical Study Report.
- Performing & reporting of system audits as per system audit annual calendar to ensure compliance w.r.to Lambda SOPs, Quality Systems and applicable regulatory requirements.
- Review and preparation of Quality Assurance SOPs, review of CTM department system SOPs and working instructions for correctness, adequacy and compliance.
- After completion of all the stages of audit for undertaken clinical trial, prepare the risk analysis of observations and suggest mitigation plan to concerned department and to share the report with management.
- Compilation of the data and updation of internal tracker/database at regular interval to perform trend analysis
- To facilitate regulatory inspections/ sponsor audits for clinical trials and to review and provide inputs to sponsor audits query/ regulatory inspection observation.
- Audits of Trial Master File, Site Master File, Protocol deviation tracker and SAE tracker at various stages of the clinical trial.
- Support Head-QA/Designee for responding to regulatory or sponsor queries pertaining to clinical trial/ sponsor audits / inspections.
- Update Head-QA/Designee regularly on the level of compliance and compliance issues.
Apply Online
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