Compliance Manager

Compliance Manager
Compliance Manager

Compliance Manager Central Imperial College, London , UK

The purpose of the role would mean you are responsible across appropriate client sites and is also part of Pharma Quality and Compliance group. The group conducts audits, provides input into training and quality investigations, all of which to ensure GxP regulations, client QMS and business critical expectations are satisfied, you will be developing, leading, and delivering QMS Standards and defined projects or solutions across the required scope of the contract. As Compliance Manager you will have a strong understanding of commercial terms, auditing, and statutory compliance in a regulated environment. You must have recent and practical experience in quality and compliance management in pharmaceutical environment. You must have recent and practical experience in quality and compliance management in pharmaceutical environment. Solid experience in auditing and report writing is also a must.

Responsibilities

Support mobilisation of new sites from a quality, compliance perspective.

Review due diligence reports highlighting specific quality, compliance and business issues.

Maintaining and developing client relationships, whilst liaising with representatives to deliver planned and reactive works.

Delivering safe systems of works via permit to work system. Ensure execution of maintenance activities are in accordance with site policies and procedures including health, safety and environmental (HS&E) and Good Manufacturing Practice (GMP).

Financial checking and authorising, invoices, and applications for payment.

Execute various processes (e.g., QMS / documentation control, change control, risk management, risk assessment, non-conformance and CAPA management, 3rd party management) in compliance to relevant standards.

Ensure statutory and compliance activities such as L8, LEV, LOLER, F-Gas and Lifts, are carried out according to current legislation.

Support mobilisation of new sites from a quality, compliance perspective.

Control of service contract execution and conducting training in QMS topics to the wider team.

Present quality compliance status information, data analysis, metrics and general overviews to client management or internal customers.

Engineering co-ordination including specialist laboratory service provider, planning and scheduling of works via Planon.

Ensure execution of maintenance activities are in accordance with site policies and procedures including health, safety & environmental (HS&E) and Good Manufacturing Practice (GMP).

Liaison with client representatives to deliver planned and reactive works controlled, using safe systems of works via the permit to work system.

Checking and authorising of works, reviewing risk assessments and method statements and to obtain quotes for planned and remedial works arising out of service contract visits.

Financial checking and authorising, invoices, and applications for payment help develop engineering and facilities scopes of work / SLA’s.

Develop, lead and deliver the QMS framework internally and across the contract. Review due diligence reports highlighting specific quality, compliance and business issues ensuring any QMS processes are effectively aligned to client QMS requirements.

Lead and support defined projects, improvements or solutions across the required scope of the contract.

Maintaining and developing the client relationship.

Effective Governance and internal communication / escalation within Integrated approach with operational Site and Above Site Management teams.

Present quality compliance status information, data analysis, metrics and general overviews to client management or internal customers.

Produce monthly reports with the data required to implement the reporting and governance programme.

Person Specification

Essential Experience Solid grounding and practical experience in working in the Pharmaceutical environment, particularly in a Quality function, laboratories and facilities management areas. Supervisory experience and performance management – both staff and contractors. HNC or equivalent in Engineering or related discipline. Have excellent technical awareness and good overview of M&E building services. Proven experience of issuing permits, writing risk assessments and HS&E active monitoring. Analytical skills: Must possess strong analytical skills. The ability to systematically gather information from a variety of sources, analyse information, and have the ability to apply Quality Risk Management processes to evaluate the consequences of choosing each alternative. Good understanding and awareness of health, safety and environmental. Good computer literacy and operation of Microsoft Word, Excel and databases. As this role interacts with senior client representatives, and senior staff, excellent communications skills (verbal and written) are required, with an ability to recognise the values within different cultures and acknowledge different ways of working.   Desirable Experience ISO90001 knowledge Project management experience Membership of professional ‘Quality’ institutions or other relevant Professional Engineering body. Developing and writing M&E scopes of work and service level agreements (SLA’s). Qualifications in Quality, Compliance and Auditing.