Quality System Specialist

2 weeks ago

Singapore Antaes Consulting SA Full time

Job Responsibilities: 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 Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills Excellent communication skills, both written and verbal, in English #J-18808-Ljbffr

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