Quality Lead & RP
Full Time Permanent Role
Greenogue
The Role
Quality Lead & RP Durbin is responsible for overall development, implementation, and maintenance of the Quality Management System (QMS) within this Business Unit. This role is responsible for maintaining the QMS in line with current GxP guidelines and regulations and ensuring best in class quality standards are maintained, across all aspects to the Durbin Ireland Business. The incumbent will work with internal and external stakeholder to maintain a QMS which provide effective and efficient processes while maintaining regulatory standards and expectations. The person will act to identify and resolve quality issues and escalate as appropriate to Senior Management. The person will act as the RP on the Durbin Ireland WDA.
MAIN DUTIES & RESPONSIBILITIES
* Responsible Person will be responsible for the compliant management of Durbin Ireland WDA and all associated GxP and Medical Device activities
* Perform all activities in compliance with Uniphar Group Policies and Procedures.
* Liaise and lead regulatory and client inspection activities as required.
* Work with the EAP Quality Lead to ensure processes and procedures are effectively documented.
* Project manage and schedule key projects and initiatives insuring timely execution and goal achievement.
* Implement and ensure compliance to the quality requirements as per Quality Management system.
* Develop staff on new quality initiatives and assist in the understanding and rollout of quality initiatives across the department/site.
* Ensure development and maintenance of Regulatory standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications.
* Identifies regulatory system enhancement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions.
* Analyse audit results and make recommendations to management on areas that may require additional staff training, improved documentation or process improvement in order to remain compliant with regulatory standards
* Effectively manage large amounts of information and documentation.
* Review requirements to provide feedback on completeness, evaluation and other risk areas that could impact quality compliance.
* Contribute to the development of high-quality systems by ensuring functionality meets documented specifications, quality requirements and organisational goals.
* Lead issue triage and resolution meetings with internal & external departments.
* Build strong relationships with business and diverse stakeholders and champion continuous improvement initiatives across the business.
* Prepare, distribute, and maintain weekly & monthly reports/KPIs summarising information regarding all the above
* Participating in continuing own and team professional development to maintain awareness in current and new regulations and ensuring new regulations are implemented
* Responsible for the management of providers and processes for any outsourced GMP activity
* Other projects as assigned by management
QUALIFICATION, EXPERIENCE & SKILLS REQUIRED
* 3 to 5 years of work experience in a regulated industry (GDP/GMP/ Unlicensed Medicines)
* Previous experience in regulatory authority inspections
* Must have ability to lead and develop a small team of people.
* Excellent communication skills and the ability to work well with people at all levels are essential.
* Must have strong organisational, analytical, problem solving, influencing and management skills.
* Project management experience is a plus.
* Knowledge and experience with software including word processing, spreadsheets, and statistical analysis.
* Ability to work in a fast-paced team environment, effective decision-making, and problem-solving skills
* Proven time management and prioritisation skills focusing on urgent and overlapping deadlines
* Strong organisational skills, attention to detail and proven accuracy with record keeping
* Ability to work independently
* Experience of Validation methodologies
* Commercial acumen
* Bachelor's degree in science/engineering related field preferred
COMPETENCIES
* Positive can-do attitude with a focus on action does not debate.
* Results orientated.
* Pursues a standard of excellence, relentlessly measuring and chasing to ensure targets met.
* Resolves conflict constructively and works well under pressure.
* Attention to detail.
* Strong communication and negotiation skills.
Company Background
Uniphar Group PLC is one of two full line pharmaceutical wholesalers operating in the Irish market. With a turnover expected to be in excess of €1.2billion for 2015, Uniphar is one of Ireland's most successful indigenous companies, managed and run from our headquarters in Citywest, Dublin. The full line wholesaler is the middle man between the Manufacturers and the Pharmacy, who receive in bulk and breaks down and delivers the medicine in average units of 2 across 12,000 products twice daily.
Active right across the pharmaceutical/health supply chain, the Uniphar Group has wholesale depots located in Dublin, Cork, Limerick and Sligo, the company has now built the strongest wholesale depot structure in the Irish market. Our Citywest Distribution Centre (CDC) is a €65M state of the art warehousing and distribution facility and is one of the most technologically advanced of its kind in Europe. This ensures that we offer an excellent distribution service to meet the needs of manufacturers, community pharmacy, hospital pharmacy and veterinary surgery across the country.
Set up 40 years ago by community pharmacists to allow them to control their own supply chain, the roots of the Uniphar Group remain in community pharmacy and ownership is still held largely by community pharmacists. Today Uniphar Group employs approximately 550 people.
In 2013, Uniphar acquired Cahill May Roberts, one of its main competitors, and since then has undertaken a serious investment in IT and infrastructure, including SAP, while integrating the two businesses. Entrepreneurial and fast moving, the company is expected to list on the stock exchange in the next few years.
In 2015 Uniphar continues to grow and has recently acquired Star medical a UK business who provides a full outsourcing and resourcing solution that delivers sales, marketing, medical and clinical people for Pharma, Medical Devices & Technology, Clinical Research and Healthcare Communications businesses; Star's tailored services include dedicated teams, vacancy management, direct to headcount recruitment, consultancy and master vendor. Uniphar also acquired Point of Care Point who is Ireland's leading community specialist healthcare provider. It provides services in the community that allow patients to be cared for in a more comfortable and less costly alternative to hospitalisation.
People & Culture
At the core of Uniphar Group are its people and our employees are the driving force of the business. Uniphar is passionate about hiring and developing high-potential individuals and giving them fast track, long-term careers.
The company hires more than anything on cultural fit and potential to grow within the business. It is a fast moving business in an industry that is going through a lot of change – this means our people have to be adaptable, quick thinking and focused on results.
In order to succeed in Uniphar you will be smart, down to earth, highly commercial and driven. You will need to be flexible in how you think and a strong problem solver. You will also need to be a good leader, able to get the best from your own team and also to work cross functionally and interact effectively with people at all levels of the business.
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