Sector: Life Sciences
Consultant: Chris Kerr
Salary: £52700 - £79100
Job Status: Permanent / Full Time
Exciting opportunity to join a well-established company based in Dublin I am currently searching for a Pharmaceutical Consultant to provide key support to the Senior Consultant in all matters relating to the provision of services to our client and customer base.
To provide key support to the Senior Consultant in all matters relating to the provision of services to our client and customer base.
The focus areas for the role will be on technical deliver of client projects, including acting as a QP, GxP compliance audits.
Under the Guidance of the Senior Consultant:-
- To liaise with customers with regard to their requirements, determining their needs and timelines and to manage client projects including the preparation of project proposals and the implementation of Project Plans including timelines and costings.
- To conduct Quality Audits for Customers in line with the company’s auditing procedures and in line with all Pharmaceutical Regulatory requirements and Standards, to highlight deficiencies to the customers and to support (as required) in the remedy of those deficiencies.
- To act as a QP
- To advise and support companies in the establishment and improvement of their Quality Systems.
- To follow-up with existing customers to ensure satisfaction with service.
- Technical management of client projects ensuring the completeness of project plans, correct allocation & implementation of timelines and project costings. To ensure all personnel and Associates are aware of their responsibilities and to monitor progress against key milestones / activity dates and report on progress to the Senior Consultant and Project Team.
- To prepare draft training material for external class-room based courses and for web based e-learning and downloadable training material.
- To co-deliver / deliver training to clients.
- To undertake ongoing Continuing Professional Development (CPD) to ensure currency of technical knowledge and skills. This includes the development and maintenance of a Technical Reference Library at the company.
Business Development / Sales & Marketing
- To keep abreast with changing Regulatory Standards, Industry Best Practice and emerging trends to provide input to business development and product development opportunities.
- To follow-up with existing clients and potential new clients to increase client base and increase sales.
- To prepare draft company publications including the Regulatory Update Bulletin and e-Newsletter, liaising with Associates, Industry personnel / sources to gain input and ideas for content.
- To input as requested into the annual budgeting process.
- To deal with internal/external customer contacts and resolve queries and problems in an effective manner and timely manner.
- To liaise with Clients, regulatory authorities and other external parties as required / requested on behalf of clients and/ or on behalf of the company
- Compliance To ensure compliance with all our company’s International company policies and procedures, including Quality Systems, and E, H&S requirements.
- To ensure all documentation prepared is in line with standards as set down by relevant Legal and Regulatory bodies.
Qualifications / Experience
- 3rd Level Qualification in Science or Quality Management
- In excess of 15 years’, experience in GMP in sterile and biotech drug products.
- 15 yrs experience in Quality Assurance or Quality Compliance role.
- High level Computer Literacy and competency – Microsoft Office, Microsoft Project.
- QP Status
- Vendor Auditing Experience Knowledge, Skills & Behaviours
- In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered).
- In-depth understanding of the purpose, objectives and scope of Quality Systems
Demonstrated ability in
- Effectively resolving compliance issues
- Working with third parties
- Creation of third party contracts / project agreements
- Working in cross-functional teams
- Contributing to company programmes or projects
- Managing change, influencing stakeholders and delivering results
- Strong Communication Skills – strong business English capability
- Strong technical writing skills
- Project Management Skills
- Strong Interpersonal Skills – when working with MPI staff, Associates, clients and external 3rd parties
Commercial Awareness – Understands the vision and strategy of the Company and takes action to support the collective objectives of the business. Networks appropriately and effectively inside and outside of the Company to build relationships in the interests of the business.
Resilience – The capacity to make realistic plans and take steps to carry them out. A positive view of yourself and confidence in your strengths and abilities. Skills in communication and problem solving. The capacity to manage strong feelings and impulses.
Emotional Intelligence – The ability to identify, use, understand and manage emotions in positive ways to relieve stress, communicate effectively, empathise with others, overcome challenges and defuse conflict.
Flexibility – Ready and able to change so as to adapt to different circumstances
Change – Resilient; flexible. Identifying improvement opportunities and embracing change, helping to overcome barriers and obstacles.