Quality Control Analyst

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.