Principal Validation Specialist
6 days ago
Anter Consulting PTE. LTD. is a renowned consulting firm specializing in pharmaceutical and biotechnology industry services.
About the Role
We are seeking an experienced Principal Validation Specialist to join our team in Singapore. The successful candidate will be responsible for leading Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical manufacturing facilities, equipment, and systems.
Key Responsibilities
- Develop and execute CQV protocols for pharmaceutical manufacturing facilities, equipment, and systems.
- Collaborate with project teams to ensure compliance with regulatory standards such as FDA, EMA, and GMP.
- Perform risk assessments, gap analysis, and prepare validation documentation.
- Support the design and implementation of validation strategies for process and utility systems.
- Lead or participate in FAT, SAT, and related commissioning activities.
- Ensure all CQV activities meet project timelines and budget requirements.
- Provide technical expertise during audits and regulatory inspections.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 3-5 years of CQV experience in the pharmaceutical or biotechnology industry.
- Strong knowledge of GMP, FDA, and other regulatory requirements.
- Hands-on experience with CQV of manufacturing equipment, including bioreactors, lyophilizers, or packaging lines.
- Familiarity with computerized systems validation (CSV) is a plus.
- Excellent analytical, communication, and project management skills.
- Ability to work effectively in cross-functional teams.
What We Offer
- Competitive salary: SGD $90,000 - $120,000 per annum.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
- Comprehensive benefits package.
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