Quality System Specialist

1 day ago

Singapore ANTAES ASIA PTE. LTD. Full time

Contribute to Life Science projects for Antaes Asia clients
- Act as a key member of the Quality Systems team, providing quality oversight for validation activities, including the critical area of Data Integrity
- Ensure compliance with regulatory standards and internal policies for all validation processes
- Collaborate with Subject Matter Experts (SMEs) and the validation team to conduct gap analysis and risk assessments prior to qualification activities.
- Identify potential gaps and risks, proposing effective mitigation strategies to ensure compliance and operational excellence.
- Participate in investigations related to validation discrepancies and assist in reviewing and approving discrepancy reports.
- Support the closure of Corrective and Preventive Actions (CAPA) associated with validation issues, ensuring timely and effective resolution.
- Review and approve a wide range of validation documentation, including but not limited to protocols and reports, ensuring accuracy, compliance, and alignment with quality standards.
- Provide critical feedback and ensure that validation documents meet regulatory and company requirements.
- Serve as a resource for validation-related queries and issues, providing guidance to teams and ensuring swift resolution of problems.
- Review and approve Standard Operating Procedures (SOPs), FORMs, Manufacturing Batch Records, and other relevant procedural documents to ensure they align with current good manufacturing practices (cGMP) and company policies.
- Contribute to the promotion of Antaes services on top of assistance provided to clients

**Job Requirements**:

- **Bachelor’s Degree in Biomedical Engineering, Biotechnology, Science or equivalent**:

- 2-4 years of experience in a Quality Systems role within the pharmaceutical or biotechnology industry
- Experience with validation processes and quality oversight, including data integrity
- Strong understanding of cGMP regulations and validation principles
- Experience with risk assessment, gap analysis, and CAPA processes
- Problem-solving ability with a focus on proactive solutions and process improvement
- Excellent communication skills, both written and verbal, in English

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