HR at Alpha MD Private Limited
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Alpha MD - Quality Assurance Lead (2-5 yrs)
Job Description:
- In-depth knowledge regarding clinical trial processes, the drug discovery life cycle, and computer systems used in clinical sciences.
- Ability to understand life sciences and healthcare regulatory reporting and compliance.
- Experience in working on documentation of system development, system testing, and the validation life cycle.
- Well versed in quality control of clinical trial processes (trial startup, trial conduct, trial closeout), site documentation, and data management workflows.
- Proficient in developing standard operating procedures for product development, IT processes.
- Ability to independently handle all audits and inspections carried out by sponsors/regulatory agencies.
- Excellent oral and written communication skills.
- Experience: Min 2 - 5 years- experience
Qualification:
- B.Sc./M.Sc.(IT)/computer science, diploma/degree in clinical research.
- Excellent verbal and written skills (English).
- Good organizational, interpersonal, and team skills.
- Ability to deliver results under pressure.
- Goal oriented, self-motivated; able to work independently but within a team environment
Desired Skills/Experience:
- Identify validation requirements country/ region wise and map product functionality and compliance.
- Define validation strategy, develop validation test scripts, validation protocol, validation report.
- Proactive in documentation system validation process and meeting project deliverables.
- Industry: Pharma/Biotech/Clinical Research
- Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
