Jobs in singapore for QA Specialist – LOT Disposition January 2013 at Roche Singapore Technical Operations Pte Ltd
QA Specialist – LOT Disposition
- 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.
- 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
Appointment to this position will be on local Singapore salary and benefits package.