Description
The successful candidate will report to the Senior Manager QA and will be responsible for the following activities:• Supervise systems associated with Site Quality Review Team
• Act as QA contact on New Product Introduction Technical Transfer Team
• Review and approve Master Batch Records
• Write, review and approve Standard Operating Procedures, as applicable
• Review and approve bills of material
• Review and approve validation documentation
• Review and approve change controls
• Provide Quality support for the investigation of all classes of Non Conformances (NCs)
• Review and approve all NCs for closure ensuring compliance with appropriate documentation
• Participate in appropriate NC related root cause analysis
• Collaborate with CAPA owners to ensure CAPA actions address root cause and implementation plan dates are achievable
• Provide training and advice to staff in order for them to perform their desired functions.
• Ensure that both self and staff operate in a safe manner as defined in the safety statement prepared by the Environmental Health and Safety Department.
• Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and company requirements, policies and procedures.
• Support Lean Transformation and Operational Excellence initiatives and participate in team meetings
• Perform all activities in compliance with company safety standards
• Ensure all GMP compliance training is up to date before performing GMP activities