Sword Achiever are currently looking for an experienced Senior IT Systems Validations Specialist with specific experience in the pharmaceutical and/or Healthcare industry. Essentials include previous experience of Computer Systems Validation (CSV), GAMP5, Part 11 and Annex 11 as well as exposure to quality management systems and auditing within a pharmaceutical environment.

Core Responsibilities

• The Computer Systems Validation is responsible for leading the work required the validation of all computer systems developed and used by Sword Achiever and for promoting the Sword Achiever quality management system throughout all work performed by Sword Achiever
• Ensure all Validation standard documents for Sword Achiever R&D division are in line with the expectations in a regulated/GCP environment, developed on time and to expected levels of quality. Define and improve the quality management system in collaboration with quality assurance
• Manage the process of validation according to procedures for all systems developed/used by Sword Achiever
• Resourcing department to meet timelines and deliver on budget
• Act as a consultant for teams on all validation issues, providing support to the operations departments and guidance to ensure the validated status of computer systems is maintained
• To positively develop relations with internal and external clients

Principal Accountabilities

• Oversee all validation activities for Sword Achiever
• Direct and execute computer validation activities in accordance with company policies, standards and regulatory expectations; includes preparation and review of validation and qualification protocols, analysis of data, and preparation and review of validation and qualification summary reports
• Assist in the establishment, execution, and maintenance of Sword Achiever Computer Systems Validation Compliance program. Verify that documented working practices reflect global regulatory requirements
• Lead and manage strategic projects that contribute to the improved state of systems compliance and systems validation; includes design and development of control processes, documentation, training and maintenance
• Assist in development of validation/systems compliance training on systems compliance initiatives. Identify process gaps and/or quality deficiencies in Sword Achiever global activities, proposing opportunities for improvement & raising awareness of unmet Sword Achiever educational needs
• Support internal Change Control procedures; provide quality systems review of applicable changes
• Promote a pragmatic, proactive and supportive culture within the company environment, which maintains an appropriate level of regulatory compliance whilst facilitating the achievement of project deliverables & timelines
• Pro-actively contribute to management team discussions by providing quality/compliance management & consultancy on international projects & overall business operations
• Direct process improvement initiatives including the creation and maintenance of SOP’s, working practices, training programs and metrics/key performance indicators

Work Experience and Qualifications

• Educated to degree level in a Life Sciences, Computing , or a related discipline
• At least 10 years’ experience of Computerised System Validation experience in a regulated Technology (software development) sector
• Thorough knowledge of regulatory environments (e.g. GCP, GAMP, ITIL, etc).
• Familiarity with Agile software development processes and Software as a Service models and their control and management according to current regulatory expectations
• Demonstrate the ability to apply business understanding to achieve quality delivery as part of a quality function
• Ability to influence and lead others, and deliver results consistently in a fast moving environment
• Proven experience in people management
• Ability to manage multiple deliverables in dynamic customer facing environment; very good project management skills

If you are interested in applying for this position, please send a CV and covering letter to info@sword-achiever.com.

Traditionally, they utilised Sword Achiever’s flagship product, AchieverPlus, to manage their quality and environmental frameworks, streamlining processes, reducing pressure on resources, improving visibility of information for dispersed and virtual teams, and reducing management travel time and expenses. However, with the addition of new regulatory pressures in the form of the UK Bribery Act, they have since utilised the software’s capabilities for other compliance challenges.

As with many regulatory and legislative pressures companies now face, compliance to the UK Bribery Act can be made easier through the automation of key processes. Through policy control, risk management and audit management, an integrate Governance, Risk and Compliance framework can be deployed to help identify, manage and control the key requirements.

In this case they needed to update and deliver their code of conduct across their organisation in 8 languages and to 850 employees. With Sword Achiever’s flagship product AchieverPlus in place, they simplified the creation and roll out of the new policy ensuring that the right information was seen across the organisation in the quickest time possible. AchieverPlus also includes the ability to record whether individuals have read and understood the new code of conduct maximising compliance and ensuring escalations with those who are yet to respond.

Alongside this, they are further utilising AchieverPlus to manage and control their HR compliances by managing the creation, review, change and archiving of equality and diversity policies in line with their corporate and social responsibility statements.

About AchieverPlus from Sword Achiever

AchieverPlus from Sword Achiever provides risk management software, quality management software and business management software solutions that enable companies to meet multiple compliances and predict and prepare against unexpected risks and incidents. For more information please visit www.sword-achiever.com or email info@sword-achiever.com

If you have any problems please email info@sword-achiever.com

If you have any problems please email info@sword-achiever.com

• Utilising Sword Achiever as a gateway to performance management
• Ensuring compliance and risk reduction through surveys and questionnaires, internally and externally
• Ensuring risk and compliance in the office and in the field through offline and mobile functionality
• Providing an enhanced controls framework to ensure a consistent, integrated and complete view of risks
• Increasing automation through a new rules engine that supports automated business processes/workflows
• Including ITGRC compliance controls with integration to the Unified Compliance Framework (UCF)

Sword Achiever, leading Governance, Risk and Compliance (GRC) software developers, are proud to announce the launch of their latest version of Sword Achiever on .NET. This R5 release has been developed to maximise user experience and provide even deeper integration with the businesses existing technology landscape. Specific highlights include:

• Updated User Interface features and enhancements
• New API to support integration with external systems
• A new add-in for Microsoft Outlook which allows for seamless integration with AchieverPlus directly from client machines

We understand the importance of user experience when it comes to businesses gaining the maximum value out of their enterprise software. Working closely with our customers we also appreciate the importance of making our software as easy to use as possible for end users and deliver relevant data to decision makers. This has resulted in improved user interface features and enhancements, greater configurable reporting and further integration.

To see more information please click on the links below:

• Sword Achiever R5 Product Introduction Sheet
• Sword Achiever R5 Product Release Notes

About Sword Achiever

At Sword Achiever, our goal is to help business leaders achieve sustainable growth through informed, accurate and ethical decisions by providing actionable intelligence to control, protect and improve key Governance, Risk and Compliance (GRC) processes.

We supply the very best in business management software and quality management software, as well as risk management software which can help your business to succeed in an increasingly competitive marketplace.

If you have any problems please email info@sword-achiever.com

Coca-Cola Sabco employs 8572 employees in 21 bottling plants across 9 countries and aim to be the best Coca-Cola bottler in the world. Their purpose is to create value for everyone touched by their business by providing, with passion and focus, the right refreshment, at the right price, in the right place. To deliver this value to their stakeholders and the wider environment the management and control of risk and compliance processes across the Group is paramount.

The Challenge

With a focus on ensuring the highest levels of satisfaction for everyone who is touched by their business, Coca-Cola Sabco strive to maximise quality and safety throughout their supply chain. To achieve this, they required a standardised solution that delivered consistency in terms of their Group quality, policy, risk and safety management. One that could control their multiple compliances, protect their business from unexpected incidents and improve processes through continuous monitoring and improvement.  

With the Lotus Notes version of Sword Achiever’s flagship product AchieverPlus already installed in parts of the Group, Coca-Cola Sabco were in favour of having the same functionality across the organisation. With each plant across their 9 geographies having their own risk register and differing solutions for ISO 9001, 14001 and OHSAS 18001 certifications, a single, consistent best practice solution was needed to control and manage the storage and reporting of risk and compliance information.

The Solution

Upon evaluating alternate systems they found that these didn’t fit into their exact business requirements with extensive customisation needed in the short term and costly developments in the future. They required a solution that was more user friendly with the option of administrator configuration instead of costly customisation and felt they would rather work with people who knew their business needs and industry intimately already. As a result, Sword Achiever’s .NET was chosen for deployment offering:

• Fast and simple implementation of AchieverPlus into Coca-Cola Sabco to enable the seamless access of information
• Executive sponsorship from Sword Group to steer the success of the project rollout
• Tailored role-based training programme to enhance quicker user adoption of the system

The Benefits

The Sword Achiever GRC solution, AchieverPlus, will enable Coca-Cola Sabco to realise significant value from the solution by delivering the following:

• Increased visibility over quality processes leading to reduced costs and minimising risk of product recalls and reputational damage
• Greater control over corrective actions maximising efficiency and ensuring objectivity and effectiveness of the audit process
• Standardised processes and reporting enabling full Group view of compliance and risks reducing duplication, increasing control and maximising resources
• Reduced non conformances and complexity with corrective actions being linked to audits, risks and documents with automatic reminders and escalations
• Greater security through role based access and full audit trails

The Future

AchieverPlus will be implemented across all 21 bottling plants across Coca-Cola Sabco in a phased release ensuring best practice implementation. This will be collaborative and inclusive, engaging with the end users to ensure take up through communication and education.

If you have any problems please email info@sword-achiever.com

As businesses look to cut costs many departments Capital Expenditure is being squeezed more than ever before. While 10 years ago it was easy to get budget sign off for systems that would improve operations, now even minimal expenditure often needs head office sign off. We see this resulting in two main outcomes. Firstly, business are looking for Governance, Risk and Compliance (GRC) software systems that can integrate with existing solutions and don’t need a complete remodelling of their IT infrastructure and secondly, business are looking more and more to spread their investment costs while still delivering business value through SaaS or subscription pricing models.

At Sword Achiever, we understand these pressures and are providing our customers with a framework that has multiple integration points. This enables to software to do what GRC software should, providing multiple checks and controls over the business as a whole, not individual silos.

In terms of the cloud, we are seeing an increase in the numbers of people who are looking for SaaS or hosted offerings, however, this method of deployment is still in the minority. Businesses often want the types of information that is stored within the system to be on their servers, behind their firewalls. While it may not be very cool to say it, we expect this to remain the case for the short to medium term. While those moving to the cloud may grow as confidence increases, we still believe the majority of enterprise GRC software sales will be on the customers premise. This means vendors will have to be smarter in terms of their licensing options to find a way around ever stricter spending constraints.

If you have any problems please email info@sword-achiever.com