Validation Specialist
We are currently recruiting for a dynamic opportunity in the pharmaceutical industry. This is an excellent position for anyone who wants to join a leading multinational company that is one of the best at what they do.
The role will be responsible for maintaining current Good Manufacturing Practices (cGMPs) for assigned areas in compliance with policies, procedures, and regulations.
1. Lead cross-functional teams to address compliance issues and achieve project milestones.
2. Participate in investigations and risk assessments related to deviations/complaints and changes.
3. Collaborate with project teams through all phases of projects - conceptual design, equipment procurement, construction, installation, start-up, commissioning, and qualification.
4. Provide quality assurance review and approval of change controls, deviations/CAPAs, SOPs, and related documentation for compliance to GMP and site requirements.
5. Ensure quality oversight of computer system validation activities following a lifecycle approach in accordance with good automation practices.
6. Evaluate new regulatory guidance and industry best practices to identify impact on quality systems and implement updates as required.
7. Assist in creating and maintaining quality policies, SOPs, and reports in line with site requirements.
8. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
9. Participate in risk management activities in line with relevant guidance and best industry practice.
10. Assist in executing the internal audit program, including performing audits as required.
11. Foster strong relationships with management and colleagues to drive a safe and compliant culture.
12. Escalate compliance risks to management in a timely manner.
13. Be flexible to take on additional tasks and responsibilities as needed.
14. Degree qualification in science/quality/technical field.
15. 5+ years' experience in Quality Assurance/Validation within the biological/pharmaceutical industry.
16. Experience in commissioning and qualification/validation of computerized systems and process equipment.
17. Knowledge of quality management systems such as Veeva Vault, SAP, Trackwise, KNEAT, etc.