Job Description
Purpose: Support validation and quality activities to ensure manufacturing processes, equipment, and systems comply with GMP and regulatory requirements, under guidance from senior validation or QA staff.
Jobscope:
- Support validation activities for equipment, processes, cleaning, and systems in accordance with approved protocols and procedures.
- Assist in drafting, reviewing, and maintaining validation documentation, SOPs, and reports.
- Support change control assessments to identify potential impact on validation and product quality.
- Review validation protocols and reports for completeness and GMP compliance.
- Participate in internal audits and regulatory inspections as a supporting team member.
- Assist in deviation investigations, including documentation review and impact assessment on validation status.
- Support validation activities for new projects and New Product Introduction (NPI) under supervision. <...
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