Technical Compliance Administrator

Job Introduction

The role of the Technical Compliance Administrator is to provide administrative assistance and support to the Technical Support Engineers with oversite from the Operational Compliance Lead, based in the Pharmaceutical Production Building and Warehouse Zone (Ops South).

The successful applicant will aid in executing compliance within the area through thorough and meticulous day to day activities which support business needs.

Role Responsibility

General:

• To play an active role in the application of policy, procedures and responsibilities throughout the Regulatory areas.
• To be part of a team to manage deviation and CAPA’s in order that timelines are achieved.
• Work with AZ and Sodexo teams to investigate root-causes, analyse and implement corrective action and preventative actions.
• Support investigations led by TSE’s and special projects as required by the Regulatory Management team.

Deviation management:

• To be expected to facilitate effective daily PDR with Deviation Managers to review progress and offer support where required.
• Organise meetings with relevant AZ QA through the various sections of the QI’s.
• Will often be required to transport paperwork around the Campus to meet with the QA and obtain signatures on behalf of the Deviation Manager.
• To provide daily updates to key stakeholders and act as the point of contact for any questions that may arise.
• To understand the investigation or CAPA at a level that will enable accurate and informative responses to any questions or points of discussion regarding status.
• To obtain product information from AZ Operations if required to link to a quality related issue.
• Build an effective relationship with AstraZeneca and Sodexo QA teams so opportunities for operational continuous improvement can be shared and implemented.
• Supports organisational improvements.
• Ensures that stakeholders deliver all actions and activities related to Deviations on time.

Operations and FM change controls:

• Management of systems documenting and controlling change in the Regulatory space.
• Prioritise demand, task manage resource requirement and co-ordinate related activities.
• Manage stakeholder involvement and updates.

Audit preparedness and management:

• Perform internal quality audits on Operational systems and documentation in the Regulatory areas to ensure standards are maintained to the correct levels and any opportunities to improve are identified.
• Provide any required drawings/documentation to the war room in readiness for regulatory audits in liaison with the Quality Team.
• Provide support for any audit requests for the Regulatory space.

MSDM and quality documentation:

• Create and administer changes to documentation.
• Responsible for reviewing technical forms and liaising with appropriate SME to ensure accuracy of data.
• Creation of technical reports to demonstrate compliance.
• Manage SOP and Form reads for Sodexo staff in the Regulated areas.

The Ideal Candidate

• Previous experience of working in a pharmaceutical environment or similar.
• Team working and customer focus.
• GxP knowledge.
• Experience in technical document writing.
• Analytical Skills: Ability to systematically gather information from a variety of sources and analyse the information.
• To have a flexible approach to work activities.
• Excellent communications skills (verbal and written) are required.
• Good computer skills (Word / Excel).
• ‘Right first time’ mind frame – to contribute to a strong Quality & GMP culture within the team.
• Ability to confidently challenge and escalate issues to the Operational Compliance Lead as required.
• Positive approach to working life.
• Must be resilient; high pressure working environment due to the complexities and demands of the area.
• Able to use initiative every day to take a hands on approach to the role.
• It is worth noting that although no technical experience is necessary for the role, a flexible/ willing and open approach to learning is required, to enable the role to be filled to its full potential.

Package Description

• Free on-site car park / Bicycle storage
• Optional paid overtime available
• Cycle to work scheme
• Showers onsite
• 20 days holiday (plus bank holidays)
• 5% pension contribution   

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