Senior Specialist, Digital and Data QA-3

Job Description

As part of the Global Quality team the Senior Specialist QA will be responsible for:

• Managing systems to ensure quality regulatory and GMP compliance expectations by
• Ensuring that all tasks are performed in accordance with quality policies and procedures satisfy the requirements of cGMP and are in accordance with the appropriate regulatory guidelines.
• Interfacing with Manufacturing IT and other internal & external entities to align with quality policies and objectives
• Providing the independent quality approval of key qualification /validation documentations such as policies procedures acceptance criteria plans protocols requirements reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle
• Ensuring that Quality Management System documents such as Deviations Complaints CAPA Risk Assessments and Change Control are raised and closed out promptly
• Support complex technical quality requirements in specific IT Infrastructure and CSV situations such as validation of new systems upgrades changes or remediation etc.
• Become a primary point of contact for the business providing advice/guidance on quality standards and expectations.
• Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports responding to findings related to IT applications automated manufacturing equipment automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
• Driving resolution of regulatory non-conformance for GMP computerized systems.
• Monitoring and communicating system health compliance and other metrics updates to key stakeholders.
• Drive continuous improvement to deliver efficiency and compliance gains. Periodically review quality systems and practices for improved efficiencies and to assure greater compliance.
• Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation maintenance and use of computerized systems.

Education Minimum Requirement:

• Bachelors degree. Preferably in Science Information Technology Engineering or equivalent.

Required Experience and Skills:

• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing IT infrastructure and/or laboratory operations.
• Experience with systems like LIMS MES SAP and Quality management systems
• Min 5 years of experience in regulated pharmaceutical manufacturing industry.
• At least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.
• Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH) with emphasis in 21 CFR Partand 820 and local regulatory expectations.
• Must demonstrate extensive knowledge of the principles theories and concepts of computerized system validation / compliance.
• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical laboratory or biotechnology manufacturing environment.
• Limited supervision required in day-to-day activities.

Preferred Experience and Skills:

• Professional Certifications (e.g. Six Sigma or certification in Project Management (PMP).
• Operate as part of a self-directed team in carrying out day to day functions and assigning priorities.
• Good understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development implementation & Operations.
• Hands on experience in a Quality and/or Compliance role in a GMP environment.
• Business engagement skills with ability to collaborate with both technical and non-technical roles.
• Multi-lingual capabilities preferred.
• Experience in leading conversation during regulatory inspections.
• Excellent oral and written communication skills including persuading others and developing cross functional relationships both at site and across sites.
• Analytical Problem-solving skills applied to issue identification and resolution.
• Listening integrating diverse perspectives adds value to the achievement of team goals.
• Timely decision making.
• Project management skills combined with a since of urgency and a proven history producing quality deliverables.
• Ability to respond to changing priorities.
• Inclusion behaviors.
• Coach and develop others.
• Advanced degree in Science Information Technology Engineering or equivalent.

Required Skills:

Preferred Skills:

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