We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Under the Guidance of the Principal 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 PharmaLex Ireland 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 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 Director/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 PharmaLex Ireland.
- 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 PharmaLex Ireland.
- To ensure compliance with all PharmaLex Ireland 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.
- 3rd Level Qualification in a scientific discipline or in Quality Management
- A minimum of ten years’ pharmaceutical experience and a minimum of five in one of the following preferred areas: Microbiology, Sterility Assurance, or Sterile/Aseptic Manufacturing
- Experience with ATMPs would be a distinct advantage
- Experience and interest in QA and Compliance, ideally with hands-on experience in manufacturing – perhaps as part of a QA or QC role – can demonstrate exposure to and understanding of manufacturing processes
- Ability to define strategic goals for PharmaLex, as well a strategic goals for partnerships with clients (e.g. contribution to RfP responses for large outsourcing projects), ability to balance client requests and company interests
- Structured, analytical, systematic and independent way of working with the ability to adjust rapidly to new, unknown, challenging situations – full discretion to drive strategy and take action consistent with operating policies
- Provide consultation to specific subjects and to extensive business process reengineering activities
- related to change management, identify and manage up/cross selling opportunities
- Ability to analyse and solve problems, and to develop pragmatic solutions at a higher level (e.g. company level).
- Ability to think laterally and make connections between specific disciplines to define holistic solutions to clients’ challenges.
- Strong communication and negotiation skills (written and verbal), proven capability to communicate critical issues and proposed solutions to senior management
- Excellent skills in presentation, with a convincing and confident appearance
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.