Quality Assurance Expert
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* Ensure quality and compliance of products manufactured by the production area, adherence to Good Manufacturing Practices and Documentation Procedures.
* Provide direct Quality support to a production area as part of a Quality IPT (Integrated Product Team).
* Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures.
* Provides presence on the shop floor to support compliance and data integrity.
* Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides.
* Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution.
* QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
* Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation.
* Participates as the quality member on cross functional projects.
* Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program.
* Provides support to internal audits and regulatory inspections.
* Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
* Drive continuous improvement and utilise problem solving tools.
* Enhance operational efficiency and resolve issues through participation in continuous improvement initiatives.
* Bachelor degree in a scientific or engineering field is required. Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment is necessary.
* This role requires a seasoned professional with the expertise in QA operations and Regulatory agency engagement. Experience with quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents is also advantageous.