QA Specialist

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