QC - Validation - Officer
QC - Validation - Officer
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Job Description
Method Validation: Execute analytical method validation and verification for raw materials in-process samples and finished products in line with ICH Q2(R1) guidelines.
Method Transfer: Support analytical method transfer activities from R&D or other manufacturing sites including execution and documentation.
Instrument Handling: Operate and maintain analytical instruments like HPLC GC UV FTIR and dissolution apparatus used in validation studies.
Documentation: Prepare and review validation protocols reports analytical worksheets and summary documents as per SOPs and regulatory requirements.
Compliance & GMP: Ensure all validation activities are performed in accordance with GMP GLP and data integrity (ALCOA) principles.
OOS/Deviation Handling: Identify and report any OOS/OOT results or deviations during validation and support investigations and CAPA implementation.
Audit Support: Maintain audit-ready documentation for all validation activities to support regulatory inspections (e.g. USFDA MHRA WHO EU-GMP).
Required Experience:
Unclear Seniority
Employment Type
Full-Time
