Compliance Documentation Specialist
The purpose of this job within DPS Compliance is to maintain and control GMP documentation and provide administrative support for compliance activities.
The description of activities contained in this job description are an overview of the description of activities related to particular service areas and may vary from time to time. It may be necessary to apply skills and expertise described in this job description to other functional areas within the client business depending on business needs.
- To provide documentation support for GMP facilities in Drug Product Supply (DPS) e.g. procedures, validation, data integrity, batch record templates, active library management
- To provide support for investigation leads and SMEs on ensuring the timely progression of quality or safety investigation records by logistics management and documentation support
- To scribe & electronically control documentation updates in accordance with procedural requirements
- To be responsible for version control & upload completed documents to designated storage such as GDMS
- To collect and measure productivity through agreed metrics
- Identify, participate and track continuous improvement activities in DPS Compliance
- Participate and support internal, corporate and external regulatory audits
- Ensure that the client gets the best possible service by continually reviewing best practice in relation to both commercial, safety and quality issues and ensuring 100% ethical work
- To learn and be aware of the client’s requirements and strive to meet or exceed those requirements keeping in mind the client process end points
- To learn to deal with client queries and contact designated personnel with any relevant information or issues relating to documentation, training and systems or the service in general
- To become fully familiar with and keep up to date with any procedural or technological revisions in their area, ensuring their training is complete and adjusting their work as required with approval from the Compliance Lead in DPS
- To keep their work space area clean and tidy in both ‘seen’ and ‘unseen’ areas
- To provide cover for other members of staff as required and for taking part in the client’s weekend rota and/or overtime schedule if ever required
- To ensure that all documentation is carried out on time, is accurate and legible and conforms to the relevant quality standards
- To keep their training records up to date and participate in and initiate training as required by the client
- To update any relevant documentation when requested
- To ensure uniformity, accuracy, reproducibility and reliability in all work practices
- Once foundational knowledge is in place start to identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement
- Adhere to Standard Operating Procedures and Standard Operating Instructions during all operations, report all non-conformities/deviations
- Respond to emergencies and offer support to DPS Compliance Lead and DPS colleagues
- Follow management instruction, ensure manufacturing and housekeeping standards are met and assist colleagues when necessary.
The Ideal Candidate
- 2-3 years’ experience within a document control environment, preferable with an HNC science discipline
- Experience in good documentation practices and filing within Pharmaceutical or other regulated industry
- A sound, fundamental knowledge of Technical Documentation Administration and document management systems is essential
- Appropriate relevant experience of Technical Documentation Administration in a GMP/GxP environment within a group organization
- Basic understanding of GMP/ Validation is desirable
- Ability to quickly learn new processes and electronic systems
- Ability to work using fully electronic media, including MS Office Word, Excel, SharePoint essential, Visio and PowerPoint desirable. Experience of Learning/ Quality Management systems would also be beneficial
- Ability to communicate clearly and to form strong working relationships with colleagues
- Ability to work in a regulated environment with some supervision and be capable of developing solutions to problems as part of a team
- Willing to operate in a flexible manner and able to reuse both internal and external experiences and incorporate them into relevant improvements. Ability to switch priorities at short notice is desired
- Good team player, organised, accurate, have strong documentation skills
- Passionate about quality and client service
- Good communication skills both internally and externally and avoids making mistakes that will hinder the understanding of his/her written and verbal exchanges. High standard of written and spoken English
Key Performance Indicators:
- Adherence to quality, GLP/GXP, safety and environmental standards is required
- Demonstrates sound understanding and knowledge of practices/concepts in DPS operations
- Decision-making is in line with completed internal training
- Remains adaptable and maintains flexibility in completing daily tasks
- Demonstration of managing own time independently with little supervision and being accountable for results
- Demonstration of responsibility and dependability.
- Full reporting of activities including discrepancies and deviations to the DPS Compliance Lead
- Support internal and external audits where appropriate
- All training (Pfizer P2L and Sodexo GREAT) to be recorded and kept up to date
- PPE to be worn at all times in accordance with SSOW
Pension, Life Assurance, Free Parking, Employee Assistance Programme, Cycle to Work Scheme, reward & Recognition Scheme
About the Company
In the UK and Ireland, Sodexo employs around 30,000 people, and partners with clients in many sectors across business and industry; schools and universities; sports and leisure; energy and resources; government and agencies; healthcare; justice and defence.
Sodexo’s connected; people-centric approach brings together a diverse range of expertise. The breadth of services it offers ranges from food and hospitality; cleaning; reception; concierge (Circles); security; property management and technical services through to data driven workplace strategy and design (Wx); employee engagement and recognition services (Sodexo Engage) and personal home services through Prestige Nursing + Care and the Good Care Group.
Vital Spaces is Sodexo’s value proposition that puts people at the heart of everything we do, bringing together services and solutions and focusing on the productivity and wellbeing of people wherever they are.
Sodexo is committed to being an inclusive employer; we welcome and encourage applications from people with a diverse variety of experiences, backgrounds and identities.
We’re a Disability Confident Leader employer. We’re committed to changing attitudes towards disability, and making sure disabled people have the chance to fulfil their aspirations.
We are building on our support to the Armed Forces community through the development of specific pathways within our recruitment process to support ex-forces personnel and reservists, those applying for jobs with us who meet the ideal candidate criteria for the role advertised are guaranteed to progress to the selection process