E-Validation Technician (Long Term Temporary Mission minimum 12 month Contingent) Join to apply for the E-Validation Technician (Long Term Temporary Mission minimum 12 month Contingent) role at WuXi AppTec
Job Summary: The Validation Technician performs validation and qualification activities, ensuring compliance with cGMP and internal policies and procedures. They are authorized to oversee external vendors performing related work.
Responsibilities: Ensure equipment, systems, and processes are qualified, validated, and maintained in compliance throughout their lifecycle.
Author and review qualification and validation documentation, including risk assessments, protocols, reports, and traceability matrices.
Execute qualifications for equipment and systems across the site, including QC, production, warehouse, facilities, utilities, and computer systems (excluding global IT systems).
Conduct validations for processes such as cleaning, bulk processing, packaging, and warehouse sampling.
Participate in the development and maintenance of local site procedures.
Contribute to risk assessments and risk management teams.
Review change controls and NEF documents to assess impacts on qualified systems and validated processes.
Develop validation approaches based on risk and scientific rationale.
Coordinate qualification and validation activities, including external vendors and internal departments.
Qualifications: BSc in Engineering or a related technical discipline.
Experience in pharmaceutical qualification and validation; experience in solid dosage manufacturing is advantageous.
Knowledge, Skills, and Abilities: Familiarity with international regulatory standards, cGxP, including 21 CFR parts 11, 210, 211, Annex 11, EU-GMP, and GAMP.
Proficient in English; knowledge of French is advantageous.
Excellent communication skills and ability to work effectively with cross-functional teams and external vendors.
Additional Details: Seniority Level: Entry level
Employment Type: Temporary
Job Function: Management and Manufacturing
Industry: Pharmaceutical Manufacturing
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