The job posting is for three positions at Axis Clinicals Limited:
1. Quality Assurance - B.Pharm/M.Pharm
- Manage SOPs, controlled forms, and personnel training records.
- Conduct internal and external audits, review study documents, raw data, and equipment validations for compliance.
- Support regulatory submissions and archive study-related documents as per guidelines.
2. Medical Writing - M.Pharm/Pharm.D
- Contribute to study design and protocol development using literature and past experience.
- Plan and perform PK analysis using WinNonlin, review clinical study documents, check concentration data, and address regulatory queries through scientific justifications and investigations.
3. Quality Control - Bioanalytical - B.Pharm/M.Pharm
- Monitor in-process quality, review raw data and method validation reports, ensure instrument calibration and compliance with SOPs/GLP.
- Handle SOPs, logbooks, sample data checks, lab cleanliness, and coordinate training and equipment calibration.
Commitment: Willing to work for at least 2 years.
Preference: Local candidates from AP & Telangana (No online interviews).
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