Are you ready to play a vital role in ensuring strong product quality in a pharmaceutical manufacturing environment?
Proclinical is seeking a QC Analyst to support quality control operations within the pharmaceutical manufacturing sector. In this role, you will ensure that all materials are tested according to agreed specifications and procedures while maintaining compliance with industry standards. This position requires a focus on safety, quality, and continuous improvement, with opportunities to contribute to audits, inspections, and technology transfer projects.
Responsibilities:
1. Test all materials in accordance with agreed specifications and procedures.
2. Qualify laboratory equipment, including URS, IQ, OQ, and PQ processes.
3. Maintain and calibrate laboratory equipment following approved procedures.
4. Manage laboratory Quality Systems and Quality Management Systems.
5. Draft Standard Operating Procedures (SOPs) under supervision.
6. Support internal and external audit processes and schedules.
7. Assist in preparing for and hosting competent authority inspections.
8. Investigate deviations and implement corrective and preventive actions (CAPAs).
9. Contribute to technology transfer projects, particularly QC aspects.
10. Implement and manage change control activities.
11. Collect data for Product Quality Reviews (PQRs) and Quality Assurance Performance Indicators.
12. Manage stability programs and associated activities.
13. Perform other duties as requested by the QC Head.
Key Skills and Requirements:
14. Strong knowledge of Quality Control, Quality Assurance, GMP, and regulatory compliance.
15. Ability to interpret complex data and present findings effectively.
16. Proficiency in computer applications such as Word, Excel, and PowerPoint.
17. Familiarity with GMP guidelines and regulations.
18. Excellent problem-solving, decision-making, and time management skills.
19. Effective communication and teamwork abilities.
20. Professional behavior and self-awareness.