Job description
Uniphar keeps growing!
The new Quality Lead & DRP will work to support the RP and the Group Quality Director in the overall development, implementation, and maintenance of the SCS Quality Management System (QMS). This role will promote compliance by leading and executing all aspects of the Quality plan including the implementation and continuous improvement of processes that effect operations and distribution compliance. In this role you will assist with identification of areas and processes which require review through the engagement of internal stakeholders in the Deviation, CAPA and Change Control process.
Furthermore, this opportunity will also see you act as a Quality support for all commercial and operational departments and act as a link between Quality Department and other stakeholders to identify and resolve quality issues, identify processes, systems, and quality requirements; supporting the Head of Supply Chain Quality / RP and in the audit and inspections process and build and maintain strong and collaborative relationships with both internal and external stakeholders.
MAIN DUTIES & RESPONSIBILITIES:
- As the Quality Lead and Deputy Responsible Person you will be responsible for the compliant management of the SCS quality management system.
- Liaise and support the RP and Quality Director in regulatory inspection activities and with pharmaceutical inspection teams.
- Perform all activities in compliance with Uniphar Group Quality standards and SOPs
- Lead the Quality team of employees and help them to achieve both organisational and personal goals
- Project manage and schedule key projects and initiatives insuring timely execution and goal achievement.
- Lead the Deviation and CAPA process for all Quality issues
- Assist in the 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 to remain compliant with regulatory standards
- Contribute to the development of high-quality systems by ensuring functionality meets documented specifications, quality requirements and organisational goals.
- Build strong relationships with business and stakeholders and champion continuous improvement initiatives across the Uniphar Group.
- Design, prepare, distribute, and maintain weekly & monthly reports/KPIs summarising information regarding Quality within the warehouse environment in conjunction with the Head of Quality for SCS.
- Participate in continuing own and team professional development in order to maintain awareness in current and new regulations and ensuring new regulations are implemented.
- Other projects as assigned by RP and / or Group Quality Director
QUALIFICATION, EXPERIENCE & SKILLS REQUIRED:
- Experience in a regulated industry preferably (GDP/ GMP).
- Excellent communication skills and the ability to work well with people at all levels are essential.
- Must have strong organisational, analytical, problem solving, and management skills.
- Knowledge and experience with software including word processing, spreadsheets, Q Pulse and iWACS and SAP desirable.
- 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 in hosting or participating in supplier audits or regulatory inspections.
COMPETENCIES:
- Team Player
- Positive can-do attitude with a focus on action
- Results orientated
- Pursues a standard of excellence, relentlessly measuring and chasing to ensure targets are met Resolves conflict constructively and works well under pressure
- Excellent communication skills
More about Uniphar!
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 hospitalization.
Come join us!
Job Types: Full-time, Permanent
Benefits:
- Company pension
- Employee assistance program
- On-site parking
- Sick pay
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Dublin, CO. Dublin: reliably commute or plan to relocate before starting work (required)
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