QA Specialist (Shift)

• Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems.
• Review and approval of SOPs, cleaning verification/validation data and other documents as necessary for the operations department.
• Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.
• Support the development and implementation of improved quality reporting measures.
• Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
• Work collaboratively to drive a safe and compliant culture on site.
• Work shift patterns in line with manufacturing operations to ensure Quality oversight as required.
• Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
• Provide quality input into decision making process on the shop floor ensuring that product quality is maintained.
• Provide training in all aspects of Quality Management Systems and GMP.
• Ensure all work is carried out in line with SOPs, training or other quality systems such as change controls where applicable.
• Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.
• Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
• Actively participate in Plant/Quality committees and works with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
• Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis.
• Be an advocate of continuous improvement in the Quality Management Systems.
• Partner with colleagues cross functionally to provide support and advice on day to day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries etc.; thereby ensuring operations is audit/inspection ready.
• Conduct area inspections for operations as appropriate.
• Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same.
• Monitoring of quality systems.
• The self-inspection program.
• Verification of the effective implementation of key GMP programs.
• Effectiveness of Preventative Actions.
• Leadership activities including selection, development, coaching, and day to day management.
• Required to comply with Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

• Degree in Quality, Science or similar required.
• Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
• Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
• GMP Audit experience in the pharmaceutical industry.

Tandem Project Management