QC / QTA Team Leader
Reporting to QTA Manager
PURPOSE OF ROLE
To take a leading role in the maintenance of safe, efficient and functional laboratories, developed to the required standards, in accordance with budget
* Develops and implements quality control systems for the Waterford QTA Labs
* Oversees the day to day running of the Laboratories supporting production areas, directing the
workload of the QTA Chemists
* Manages the site analytical support, plus transfer of methods and specifications associated with
new product introductions
* Provide analytical services and support to manufacturing.
* Ensure QTA laboratories meet current Good Laboratory Practice (cGLP) and validation
* Manage teams to ensure team members achieve their potential and the team meets its goals
* Ensures projects are managed in conjunction with all required Sanofi and legal requirements
(EHS, cGLP, method transfers, environmental etc). This includes new product introductions,
cleaning analytical methods, and similar projects.
* Implement continuous improvement projects as required.
* Ensure adequate oversight of manufacturing aseptic practices.
Degree in Science (Chemistry, Microbiology or Pharmacy preferred)
Post-graduate studies as appropriate to augment primary degree
* Detailed knowledge of Biopharma analytical methodologies and technologies.
* 4 -6 years' experience working in a Healthcare manufacturing environment - ideally part of which
would be in the pharmaceutical or biopharmaceutical sector.
* Effective technical knowledge of Biopharmaceutical manufacturing
* Prior experience in leading or co-ordinating a team would be an advantage.
* Operational experience of quality laboratories in a fast moving manufacturing environment.
* Detailed knowledge of quality management systems.
* Effective technical knowledge of pharmaceutical plants.
* Knowledge of requirements for cGLP, cGMP, pharmacopoeial methods and stability.
* Ability to manage projects to plan/budget
* Excellent & efficient communicator at organisation, team and individual levels
* High energy, commitment and flexibility.
* Ability to work independently and adapt.
* Excellent leadership skills with ability to influence and affect change
* Capable of resolving issues of conflict effectively within a team
* Ability to understand the 'broader picture' and business context
* Ability and willingness to identify opportunities to 'break the mould' with systems and processes
May be required to deputise for QTA Manager
* Excellent communication skills (interpersonal, presentation & writing)
* Ability to effectively communicate technical & non-technical information
* Works well with others at all levels of the organization, across multi-sites, and in a multi-national
* Initiative - able to work in a self-directed manner to see issues through to completion.
* Highly motivated. Ability to multi-task
If you wish to have a confidential conversation about this role please call Sandra 086 044 3460 or email