Quality Assurance Specialist

The position includes all aspects of quality assurance for all companies in the group. Job includes: Drafting new SOPs and updating existing SOPS and reports according to GMP and GDP regulations. Build and follow up work processes, set yearly training and conduct continuous training sessions for employees and suppliers. Document training. Conduct validation and monitor prevention and improvement activities (CAPA). Assist in preparing for inspections, executing internal auditing and partner audits as needed. Qualify suppliers, manage investigations and deviations. Risk management and support regulatory and operations divisions. Prepare specified yearly quality reports and be of assistance to manager in any way required.

Quality activities are not inspections, rather supervision. The purpose is to coordinate the company's management and regulatory efforts in a specific field.

Responsibilities:
Ensure that the quality assurance system is implemented in a way that the approved activities can be managed.
Ensure precision and quality where listed and approve inspected documents.
Supervising that employee training is implemented and maintained.
Handle changes and deviations according to managers' requirements. Implement preventative and correction measures when necessary.
Ensure implementation of periodic management survey.
Ensure implementation of risk management.
Ensure that suppliers and partners are approved and qualified.
Approve every activity performed by sub-contractor that may indicate the quality of the products.
Implement and ensure that internal inspections are carried out regularly and according to a set plan and ensure that corrective actions are set up after inspections.
Keep account of all assignments carried out for person/company.
File all relevant documentation.
Carry out any task requested by superior.
The role includes leading, coordinating and performing, validation and calibration activities in the warehouse areas and distribution-- vehicles. Occasionally, early work hours are require.