Job Description
The QA Executive Level III role is responsible for leading quality management system elements, including GMP investigations, Change Control, CAPA and Risk Assessment and Customer Quality Complaints/Medical Device Vigilance systems.
This position will also support the Qualified person(s) to lead and perform data review audits (Batch Packaging Records, Warehouse Documentation, Engineering Documentation, Validation Documents and Development Documentation)
Additionally, this role will assist in the definition and maintenance of the annual internal audit programs, and Quality management reviews for our organization.
This includes supporting the Quality Manager in meeting the needs of the growing business; using technical expertise, skills knowledge and experience as required to resolve problems and share knowledge
This role will also support the introduction and qualification of new equipment and new products.
Furthermore, this position will involve reviewing and approving suppliers / service providers including supporting with audits of critical suppliers where required
Supporting the Quality Manager with hosting external audits and regulatory inspections is also a key responsibility of this role.
As a QA Executive Level III, you may act as principal project quality lead for new and existing projects providing advice and guidance to operational teams with support and guidance from the Quality Manager.
Assisting the Artwork team in implementation, update and obsoletion of artworks, as required is also an important part of this role.
Creating, maintaining and delivering training in quality related topics to personnel is another key responsibility of this role.
Supporting the Quality Assurance team in preparation of monthly/quarterly/annual reports to be submitted to senior management and departments to ensure visibility of QMS requirements and performance including the compilation of quality metrics to facilitate monitoring and management of the Quality System is also a key task.
Required Skills and Qualifications
* A minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 2 and at least 5 years relevant experience within a relevant sector (i.e pharmaceutical/medical device industry) with a minimum of 3 years' experience within a Quality Assurance role.
* Experience in a Quality Assurance role in a Pharmaceutical/Medical Device Packaging Department is desirable but not essential.
* Excellent communication (oral & written) and interpersonal skills are required for this role.
* Able to handle multiple tasks in a fast paced environment with strong organisational and time management skills.
* Competent in the use of Microsoft Excel/Word.
Benefits
Our organization offers competitive salaries and benefits to its employees.
We also provide an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Our organization is an Equal Opportunity Employer.