QC Micro - Sr Officer - Documentation
QC Micro - Sr Officer - Documentation
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Job Description
Documentation Management: Maintain review and update SOPs protocols test reports and validation documents as per GMP GLP and data integrity guidelines.
Regulatory Compliance: Ensure all microbiology documentation meets the requirements of USFDA MHRA WHO and EUGMP regulatory agencies.
Audit Readiness: Prepare and organize microbiologyrelated documentation for internal and external audits ensuring compliance with industry standards.
Training Coordination (DTC Role): Develop and implement training programs for microbiology personnel maintaining training records and ensuring adherence to department learning objectives.
Quality & Process Improvement: Support continuous improvement initiatives by identifying gaps in documentation and training ensuring alignment with regulatory requirements.
Data Integrity & Record Keeping: Ensure accurate complete and compliant data management in microbiology testing records sterility reports and trend analysis.
CrossDepartment Collaboration: Coordinate with QA QC and Production teams to ensure smooth workflow and compliance with microbiology protocols.
Required Experience:
Senior IC
Employment Type
Full-Time
