Data Quality Assurance Manager
2 days ago
SRG is working with a leading life science organization to find an experienced QA professional for a new role. This is a great opportunity for someone looking for a new QA challenge with great benefits and flexi-time on offer.
The Role:- Compliance governance of key quality system elements, including scheduling and completion of quality management reviews, vendor qualification, PQRs, audits, and self-inspections.
- Maintain site establishment registrations with regulatory agencies as applicable.
- Manage updates to drug master files and issuance of regulatory compliance reports.
- Coordinate tracking of site compliance commitments and follow-up actions.
- Coordinate and support the delivery of quality compliance metrics/KPIs to key stakeholders.
- Identify GxP trends and communicate these to relevant stakeholders.
- Support compliance risk management activities and implementation of risk mitigation plans.
- Work with the wider site functions to drive down out of compliance events, identify, and implement quality improvements.
- Coordinate QMS training for site employees and ensure this adheres to current regulatory requirements.
- Support and track regulatory findings and trends that may lead to a focus on regulatory inspections.
- Act as a single point of contact between site and corporate quality team as delegated by QA manager.
- Assure compliance of procedures according to internal guidelines and UK/EU/US/ICH and other region-specific guidance.
- Lead quality management review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken.
- Support quality-related investigations, assist in the development and approval of effective CAPA to resolve product, audit, and customer issues.
- Support effective pre-audit preparation, management, and post-audit follow-up of customer audits and regulatory inspections.
- Keep up to date and integrate current quality standards, guidelines, and best practices on site. Ensure compliance by promoting understanding of the underlying concepts.
- Educated to degree level, ideally within a relevant scientific subject.
- Experience working within a GMP manufacturing environment.
- Strong knowledge of GMP and pharmacopoeia guidelines.
- Experience of performing self-inspections and audits of 3rd party suppliers.
- Monitoring of QMS, including deviation/investigation/CAPA/complaints.
- Experience with implementation of audit and vendor assurance processes.
- Strong communication skills.
- Ability to prioritize and delegate workloads to deliver on customer requirements.
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Data Quality Assurance Manager
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Falkirk, Falkirk, United Kingdom SRG Full timeJob Title: Data Quality Assurance ManagerSRG is seeking an experienced Data Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Key Responsibilities:Develop and implement quality management systems to ensure compliance...
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Data Quality Assurance Manager
5 days ago
Falkirk, Falkirk, United Kingdom SRG Full timeJob Title: Data Quality Assurance ManagerSRG is seeking an experienced Data Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Key Responsibilities:Develop and implement quality management systems to ensure compliance...
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Falkirk, Falkirk, United Kingdom SRG Full timeJob Title: Data Quality Assurance ManagerSRG is seeking an experienced Data Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Key Responsibilities:Develop and implement quality management systems to ensure compliance...
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Data Quality Assurance Manager
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Falkirk, Falkirk, United Kingdom SRG Full timeJob Title: Data Quality Assurance ManagerSRG is seeking an experienced Data Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Key Responsibilities:Develop and implement quality management systems to ensure compliance...
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