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. Assist in periodic review of validated systems and support Continued Process Verifi...