- B.Sc. / B.A in a science or related field as a minimum (or equivalent as outlined below).
- Relevant qualification and equivalent experience may replace requirements for degree (i.e. HND with 4 years additional workplace experience).
- Minimum of 7 years’ experience in the Quality / Regulatory field.
- Minimum of 12 years’ experience in related Pharmaceutical or Healthcare Industries.
- Minimum of 5 years resource supervision experience required (circa 5 plus resources).
- Minimum of 5 years Project Management experience in related field.
Summary of Role:
Management and execution of site based qualification projects in the UK and Europe. Contribute to the company in areas such as knowledge development and transfer to other team members. In this role, you will get the opportunity to get involved in the full life cycle of projects including design, engineering, commissioning and qualification within a GMP environment.
This is an excellent opportunity to join an expanding team in an award winning company operating in the UK and Belgium, specialising in Pharmaceutical, Biotech and Life Science sectors with a broad customer base including large corporate clients.
The role will be based at our offices in Send, Woking, Surrey with travel to various client site locations in the UK and Europe and requires a full driving licence.
Core Competencies Required:
- Experience in program management associated with development of documentation, execution, development of summary documents and development of Standard Operations Procedure.
- Working knowledge and practical experience in the management of Regulatory and Quality oriented projects from development of documentation through to execution activities and report development.
- Experience of project planning. Typically utilising packages such as MS Project to define project baselines in order to effectively monitor, control and forecast project resource requirements and cost.
- Able to successfully develop and lead project teams to deliver objectives. To progress, monitor and report on the execution of multiple regulatory/Quality oriented tasks on a routine basis.
- Provide subject matter expertise within the organisation and in the delivery of client projects. Nature expertise likely to be project management or related to holders technical qualifications and background.
- Strong organisational, communication and management skills with clients, colleagues, supply chain and third parties.
- Develop, establish, organise, lead, coordinate, manage and control projects and project teams, and ensure the proper execution of their part of the Company’s business, with emphasis on ensuring efficiency and contractual, legal, safety, quality, cost and time compliance in projects and in the project process.
- Implement and maintain suitable project procedures, controls and records in accordance with prevailing good practice and Company QA procedures including, but not necessarily limited to, where related to: contract, scope, health & safety, programme, cost, quality, risk, value, procurement, configuration & change control, communications, roles & responsibilities, disputes, project finances, completion, etc.
- Act as the lead project interface between the Company and others. Lead the project co-ordination and communication process internally and between the Company and others including, but not necessarily limited to suppliers, contractors, client, statutory bodies, the public and other third parties.
- Ensure that prevailing good practice and the project and Company QA systems are the basis of all project work. Assist in Quality Audits of the project team and its work.
- Establish and maintain detailed deliverables requirements on projects, including scheduling the necessary resource allocation to produce the required deliverables within the scope, safety, cost, programme and quality parameters of the prevailing contract. Develop cost estimates for alteration orders where applicable.
- Carry out detailed resource and time planning for projects. Keep resource planning tools up to date in connection with the projects being managed.
- Manage resources to produce the required deliverables for projects, including the ongoing monitoring and reporting of resource usage, earned value, compliance and other requirements. Implement appropriate actions to address variances.
- Provide suitable project reports regularly to the Company, and attend regular project reviews with Company management.
- Hold and record regular project progress reviews with the project team. Provide appropriate information to Management to enable effective reporting and to enable variances to be addressed.
- Actively pursue ongoing improvement in quality, efficiency, innovation, etc. within projects and the project team.
- Take part in business development, presentations, work proposals and tenders. Ensure that project deliverables, related quality and resource requirements are suitably defined within such submissions.
- Undertake other roles as necessary within projects our consultancy support. For example provide Audit support or input into design and build projects
- Undertake suitable and sufficient Continuing Professional Development (CPD) to ensure competency in accordance with the standards reasonably required of the role, maintain adequate records, and provide such records to the Company.
- Arrange and carry out the assessment and training in quality and other project matters to ensure that the project team and all of its members are competent and effective. Provide mentoring, development, support and feedback to the project team.
- Maintain positive, constructive, honest and appropriate relationships with the Company, its personnel, supply chain, associates, clients and others.
To apply for this position or request more information, please email your CV to [email protected] with contact details and availability. Please do not respond if you are representing a recruitment agency.
Note: The UK Government requires individuals from countries outside the European Economic Area (EEA) to be in possession of a valid work permit to allow them to take up employment (for more information please visit the Government’s website http://www.ukba.homeoffice.gov.uk/workingintheuk ). Scitech Engineering do not provide sponsorship for visa applications, facilitate work permits or enable UK entry work visas for any role advertised. All applicants must hold a valid permit to work in the region required by the role, prior to application, in order to be considered.