The Quality Team Lead role requires a thorough knowledge of Good Manufacturing Practice, & current FDA & EMEA regulations
Quality Team Lead role: Pharmaceuticals: South Dublin
The Quality Team Lead role requires a thorough knowledge of Good Manufacturing Practice, & current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use. Strong organizational, supervisory and leadership skills are required. A high level of initiative, project management skills and good verbal and communication skills are essential. Good technical writing skills are also required. The ideal candidate should be able to lead a team of analysts to achieve department and company goals.
- Provide oversight and management of elements of the Quality Management System (QMS), which includes, but not limited to, Change Management, Inspection management, Document and Learning Management, Metrics/KPIs, Commitment and Risk management.
- Management of specific GMP Quality Systems as required in accordance with the EU GMPs, FDA requirements & ICH guidelines
- Preparation, Management and Review of Quality documentation (Standard Operating Procedures, Specifications, Guidelines, Protocols etc.)
- Assist in implementation of global standards and procedures into the site Quality Systems.
- Liaise with Qualified Person on daily basis to maintain the batch approval schedule and assist with all relevant documentation requirements.
- Train QA staff on all aspects of batch review and approvals and maintain oversight.
- Assist, coordinate and participate in Learning Management
- Assist, train QA staff and maintain the Environmental Monitoring program.
- Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews.
- Lead /participate in the self-inspection program.
- Lead, train QA staff and participate in the Quality Oversight program.
- Support the Vendor Audit Schedule as required.
- Assist in Corporate and Customer audits and to act as a member of the QA team as required..
- To actively support the development/implementation and continuous improvement of the Quality Management Systems.
- Assist in GMP & Continuous Improvement projects
- Actively support New Product Introductions
- Communication and liaison with and support of other departments on Quality Issues/Projects as required
- Motivation, training, discipline and appraisal of relevant Quality staff.
- Co-operate with Manager, Quality in the completion of specified projects.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values within the workplace.
- Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
Education and experience:
- Primary Degree in Scientific or relevant discipline
- QP qualified as per Article 49 of Directive 2001/83/EC is desirable
- Have a minimum of 5 years experience in the pharmaceutical industry, preferably in a QA role
- Demonstrable experience managing, motivating and leading a team of analysts
- Ability to promote teamwork by fostering a supportive and inclusive team atmosphere and to Focuses people on key priorities and guides them to achieve their goals
- Ability to address performance issues on a timely basis and establishes specific plans to help team members reach objectives
- Ability to provides team members with timely, constructive feedback, coaching and support to help them recognize and take action on their strengths and development needs
- Ability to adapt to changing priorities
- Good organizational, investigational & technical writing skills are required
- Be a self starter who is motivated & innovative
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.