QA Specialist - LOT Disposition Information

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Roche Singapore Technical Operations Pte Ltd

The Roche Group, including Genentech and Chugai, has brought many highly effective drugs onto the market and is a world leader in innovative cancer drugs. Other areas include viral infections, metabolic, central nervous system disorders and inflammatory diseases. Read More

Address	298 Tiong Bahru Road #16-01/06 Central Plaza Singapore 168730
Website	www.roche.com.sg/portal/eipf/singapore/sg/c
Holding	No Holding Details

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QA Specialist - LOT Disposition

Key Responsibilities: Responsible for coordinating and performing drug substance and drug product lot final review & disposition activities in accordance with procedures, performance measures, and standard lead times. Perform assigned tasks and work to achieve company goals and department objectives. Collaborate with Management to establish and meet targets and timelines. Manage competing priorities. Identify, design, and implement process and system improvements. Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance Lead and/or participate in the design and implementation of department and cross-functional initiatives or teams. Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies. Perform any other tasks as requested by Management to support Quality oversight activities. Support discrepancy investigations. Support regulatory inspections. Ensure batch production was performed in compliance with requirements, and any discrepancy is properly assessed per the applicable procedure. Provide technical assessment and approval for changes & controlled document revisions. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Train personnel and internal customers on relevant business processes. Provide input to the development of personal performance goals and departmental objectives. Provide input into the design and presentation of departmental performance metrics. Serve as a technical subject matter expert (SME) in support of department functions. Technical Duties/Responsibilities: Final review of executed batch records. Compilation of Batch History Record and lot release documentation Interface with appropriate departments to ensure that lot disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided Provide technical assessment and approval for controlled document changes Revise/ review standard operating procedures to ensure compliance with QA Policies and Standards Assists in writing and gathering data for annual product reviews. Tracks and reports performance metrics as required. Maintain a state of inspection readiness. Perform reviews of investigations for potential cumulative effect to product. Review lot release documentation and perform lot disposition. Manage and schedule lot disposition activities and resources to ensure adherence to schedule. Who you are You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. Requirements: BSc degree (preferably in a Life Science) and at least 2 years experience in the pharmaceutical, biotechnology or related industry or an equivalent combination of education and experience. Sound knowledge of cGMPs or equivalent regulations Ability to interpret and relate Quality standards for implementation and review Ability to make sound decisions about scheduling, allocation of resources, and managing priorities Ability to communicate clearly and professionally both in writing and verbally Flexibility in problem solving and providing direction and work hours to meet business objectives