Digital QA Quality Assurance Lead
5 days ago
Lifelancer is seeking a seasoned Senior Quality Manager to join our team in ensuring compliance and adherence to company standards and regulatory requirements.
The ideal candidate will have a deep understanding of Computer System Validation Methodologies, risk-based system validation, and GxP regulatory requirements.
Job SummaryWe are looking for a highly skilled Senior Quality Manager to provide QA compliance oversight during the implementation and maintenance of computerized systems within RD, Corporate and Manufacturing Functions.
This role acts as an expert in quality risk management, Computerised Systems validation best practices, and industry standards. The successful candidate will be responsible for auditing internal processes, systems, and vendors to ensure compliance with company standards and regulatory requirements.
Responsibilities- Provide independent quality review and approval of validation deliverables associated with assigned systems.
- Verify that data integrity principles are adhered to within the company.
- Complete relevant testing reviews to ensure that critical scenarios have been appropriately identified and test coverage is adequate.
- Provide expert advice to business owners, system owners, Information Services Compliance team, and wider business operations.
- Collaborate with cross-functional teams to identify and resolve issues related to computerized system validation.
- 10+ years relevant work experience in the Pharmaceutical, Biotechnology, or a related industry within Quality Assurance Department.
- Minimum of 5 years experience overseeing validation and implementation of computerised systems within a regulated framework.
- Minimum of three years experience in life sciences auditing, holding a relevant Lead Auditor certification.
- Detailed knowledge of Computer System Validation Methodologies and sound understanding of risk-based system validation.
- Solid Knowledge of GCP, GLP, GMP, and/or GVP regulatory requirements.
- Excellent attention to detail and the ability to identify the root cause of problems.
- Ability to prioritize and manage multiple projects effectively.
- Ability to analyse and evaluate complex technical and professional work activities.
This estimate is based on national averages and may vary depending on location and other factors.
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