Quality Specialist / fixed term
GSK
Athens, Greece
πριν από 5 μέρες

Quality Specialist ( fixed term)

Job purpose

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.

Key responsibilities

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

  • Understanding in quality assurance systems particularly in the areas of distribution, batch release, product incidents, artwork control and audits
  • Understanding regulatory requirements pretraining to GMP / GDP
  • Knowledge of effective quality documentation systems
  • Fluent English, Strong general computer literacy with Intermediate skill in Microsoft Word, Excel, PowerPoint and Outlook
  • Key Competences

  • Good written and verbal communication skills
  • Analytical mind and good problem-solving skills
  • Good time management skills
  • Works with a spirit of continuous improvement nd innovation, creatively open to new ideas and methods
  • Good team player works well in cross-functional teams
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

    GSK is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity / expression, age, disability, genetic information, military service, covered / protected veteran status or any other federal, state or local protected class.

    Important notice to Employment businesses / Agencies

    GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

    All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK.

    In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

    This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements.

    For more information, please visit GSK’s Transparency Reporting site.

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