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Quality Analyst - (Pharma experience required)

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Quality Analyst - (Pharma experience required)

Key Accountabilities 1. Sample Analysis and Testing Perform analysis of assigned samples using appropriate, validated procedures and calibrated instruments to ensure compliance with set specifications and standards. Conduct chromatographic tests such as HPLC, GC, FTIR, and UV independently. Analyze finished product (FP) samples as per the testing schedule and release commitments. Review and evaluate test results against specifications, ensuring accuracy and compliance. Adhere to Good Laboratory Practices (GLP) and Good Documentation Practices (GDP). 2. Documentation and Compliance Record all activities online using approved formats/templates to ensure correct, accurate, and authentic entries. Maintain system integrity by updating documentation and reporting deviations during operations. Ensure timely completion and maintenance of online documentation and supporting records. Prepare and update documents as per GMP requirements. 3. Laboratory Maintenance and Safety Ensure proper disposal of analyzed solutions and samples as per valid disposal procedures to maintain compliance with GLP. Maintain laboratory cleanliness, equipment, and work areas in accordance with SOPs. Conduct validation, qualification, and calibration activities as per schedule and update records accordingly. Follow all safety norms and ensure compliance with standard operating procedures (SOPs). 4. Communication and Teamwork Maintain effective communication and professional relationships with team members and internal/external customers. Work collaboratively to foster a positive and progressive laboratory culture. Participate in GMP or customer audits as required. 5. Process Improvement and Cost Optimization Provide suggestions for cost savings and process simplification. Identify areas for improvement through operational studies and implement process development projects. Drive automation initiatives for continuous process improvement. Major Challenges and Solutions Delays in analysis due to frequent changes in planning : Addressed by conducting performance dialogues and priority meetings. Instrument breakdown causing delays : Resolved by ensuring timely availability of spare parts and service engineers. Batch release delays due to non-availability of standards, glassware, or chemicals : Managed through coordination and escalation. Key Interactions Internal: Lab Planning (Daily) Quality Assurance (QA) for non-conformances (As needed) Lab Assistant for chemical and standard requirements (Daily) External: ~ Service Engineers for instrument-related issues and breakdowns (As needed) Performance Metrics Number of FP batches released: 5 batches/month OOS/OOT non-conformance closure: Within 7 working days Non-conformance rate: Below 1.5% Maintaining strong professional relationships with colleagues Decision-Making Responsibilities Decisions: ~ Timely and accurate reporting of non-conformances to the supervisor for appropriate action. Recommendations: Suggestions for improving QC productivity to Head QA/QC. Procurement of necessary instruments, glassware, and standards to Head QA/QC. Idea generation for process optimization and work simplification. Skills & Knowledge Educational Qualifications: B.Sc. in Chemistry or Bachelor of Pharmacy. In Dutch terms, MBO (Secondary vocational education) with 5+ years of experience OR HBO (Higher professional education) with 1-3 years of experience. Relevant Experience: ~1-3 years of experience in the quality control function of a pharmaceutical organization.

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