QA Specialist (Engineering/Validation)

We are seeking applications for an experienced Quality Assurance for Validation/Engineering for our client, who are a leading biopharmaceutical company. 

This responsibility includes the oversight of the client facility’s QMS to ensure that quality and compliance requirements are followed in line with business needs, including cGMP Biopharmaceutical and Medical Device quality standards. 

This key role must ensure effective interaction the Operations, Engineering and CQV functions together with major stakeholders such as Artwork, NPI, Supply Chain, External Quality, QC, IT, and QPs to ensure the reliable delivery of quality, safe, effective product to patients.   

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.

<>·Provide QA support for Risk-Based Verification (RBV) and Computer Systems Validation (CSV) activities in the capacity of Quality Assurance Subject Matter Expert.

• Review and approval equipment/utilities verification documentation from design to post execution.

• Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
• Review and approve Validation protocols / reports as required.
• Provide quality support for serialization of Finished Products
• Support the vendor quality management program including generation and review of Quality Agreements
• Provide oversight to continuous quality system improvements and support implementation of improvements at the facility in compliance, Preventive Maintenance, Deviation Management, and the Change Control Programs.
• Provide QA and compliance support to projects, including NPIs, for the client’s packaging activities.
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
• Provide Quality input, oversight and guidance to the client’s deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per SOPs and QMS.
• Provide Quality input, oversight, and guidance to change controls, supporting risk assessments as required.
• Review and approval of functional area documentation (SOPs, Packaging Instructions, Work Instructions, technical protocols, and reports)
• Leading actions assigned to the facility from complaints process
• Define and report standard quality KPIs with recommendation for actions for improvement in relation to client operations.
• Supporting ‘right first time’ and continuous improvement from a systematic and compliance perspective

• Minimum 5 years in international Pharmaceutical and/or Medical Device industry with increased level of responsibility
• Minimum 3 years of experience in QA technical role. Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
• Ability to operate efficiently in a complex matrix organization and international environment
• Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
• Good knowledge of relevant computer packages e.g. Trackwise, SAP, Tracelink and documentation systems
• Excellent accuracy and attention to detail
• Planning and organizing skills are required to plan, execute, and track commitments of Quality Assurance and to adjust to changing priorities
• Ability to represent the client’s interests, objectives, and policies in a responsible and professional manner