Job Description
Responsibilities:
- Provides expertise in performing Computerized Systems Validation.
- Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
- Perform collaborative work with the Compliance Engineering team on other CQV activities.
- Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
- Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
- Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
- Investigate deviations and write deviation reports and findings.
- Raise and follow-up change control records.
Requirements: ...
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