Quality Specialist ( fixed term)
The role of Quality specialist exists in support of Quality Assurance operation within the commercial Cx LOC Greece, to ensure that the mandated Quality Management System requirements are met.
Act as a Responsible Person (RP) during release process.
Management of Quality Complaints.
Interface with consumers and customer to collect the necessary information for the management of the complaint
Interface with manufacturing sites to request the investigation
Processing of the response to consumer and customers
Management of Reconciliation for PQCs
Preparation of complaint trending
Support with regards to Complaints handling, audits, reconciliation with Consumer Relations
Tracking management of Deviations / Non-Conformities & Change Controls
Management and Control of repackaging activities
Support preparation of Quality Council and any other management / business review
Co-ordination and approval of local procedures - QMS implementation support
CAPA management Administration
Supports Quality Agreement management
Backup for Quality Activities in CERPS (SAP).
Reporting of Quality Metrics in KPI Dashboard
Periodic Product Review review
Training matrix update support
Self-inspection / audit universe updates
Knowledge / Education / Experience Required
University diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent in Greece, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines : pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology.
The minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level
Knowledge of regulatory requirements pertaining to GMP / GDP.
Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
Knowledge on effective quality documentation systems
Minimum of 2 years experience within the Pharmaceutical / Consumer Healthcare Industries, preferably in the capacity of a quality specialist or a manager or in a Quality Control department
To understand ways of working in a Regulated Industry
To understand ways of working in a Regulated Industry and to take appropriate decisions for all quality matters.
Preferred Skills and abilities
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