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Responsibility for the day-to-day management of Quality Control / Quality Assurance functions within the company.

Acting as Qualified Person on behalf of the company responsible for the review of batch manufacturing records and manufacturing release follow up on product complaints/ recall where necessary decisions in compliance with all license requirements.
Implementation of quality cost/awareness programme and budgetary control.

Roles / Responsibilities:
Liaison with other departments with regard to technical upgrades and new product developments.
Managing process changes either pro-active or regulatory driven. This includes process changes in response to local events such as equipment failure, abnormal analytical results or local environment. Such changes and additional work must be fully documented to ensure compliance with regulation.
Managing and participating in projects as the QA representative to meet business and compliance objectives, including modernization of the QA/QC facilities.
Participating in GMP audits carried out by customers and regulatory agencies. Producing reports on the audits and ensuring corrective actions that may arise as a result of the audits are implemented.

Skills / Experience:
Supporting the QA auditors in ensuring GMP compliance both within the company and at its key suppliers.
Managing the training and professional development of his/her staff in a harmonious and productive environment.
Advising as part of the site management team, on QA/Compliance issues to ensure supply chain integrity.
Contributing to QA policy development within the company.
Reporting regularly and in a timely manner to the VP Operations or his designee.

Education / Professional Qualifications:
A primary degree within a scientific discipline.
Postgraduate qualification allowing the applicant to act as a Qualified Person within the EU

Personal Attributes:
Excellent organisational skills with the ability to prioritise and project manage all work by delegating effectively within a team environment.
Excellent communication skills both written and verbal
A keen eye for detail and accuracy
Self motivation and initiative with the energy and enthusiasm to develop this role
Good interpersonal skills, building strong working with relationships with stakeholders both internal and external.