Key Responsibilities:
- Develop, write, and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, and systems in the pharmaceutical manufacturing environment.
- Perform process validation for manufacturing processes, ensuring products are consistently produced and controlled according to quality standards.
- Conduct cleaning validation to confirm the effectiveness of cleaning processes in preventing contamination.
- Collaborate with cross-functional teams including Quality Assurance, Production, Engineering, and R&D to ensure validation activities are aligned with project timelines and regulatory requirements.
- Perform risk assessments and develop validation strategies for new or modified equipment, processes, and systems.
- Review and approve validation documents, ensuring they comply with regulatory guidelines, industry standards, and company policies.
- Troubleshoot and resolve validation issues that arise during production, ensuring timely remediation.
- Maintain detailed validation records, ensuring traceability and documentation for audits and regulatory inspections.
- Support regulatory inspections by providing validation documentation and answering questions related to validation processes.
- Stay updated on changes in regulatory requirements and ensure the company’s validation practices are aligned with the latest standards.
- Provide training to relevant staff on validation processes and protocols as required.
Qualifications:
- Bachelor’s degree in Chemical Engineering, Chemistry, Life Sciences, or a related field.
- 3 years of experience in validation within the pharmaceutical or biotech industry.
- In-depth knowledge of validation principles, including equipment qualification, process validation, and cleaning validation.
- Familiarity with Good Manufacturing Practices (GMP), FDA regulations, and other industry guidelines (e.g., ICH, EU GMP).
- Strong problem-solving and analytical skills, with the ability to troubleshoot validation issues.
- Excellent communication skills, both written and verbal, for writing protocols and reports as well as interacting with cross-functional teams.
- Detail-oriented, with strong organizational skills and the ability to manage multiple validation projects simultaneously.
- Proficient in using validation software and tools (preferred).
All qualified applicants, please send in your resume to:
Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599
