JO-1201-240600
Deviation CAPA specialist audit GMP assurance quality
Cork
See description
4 - 5 Years
Contract
Third Level Degree
Carmel Egan
cegan@kenny-whelan.ie
Quality Assurance Specialist
In partnership with its client Kenny-Whelan & Associates is currently seeking a QA Specialist for the Cork area.
The Client:
The Client is a well established multi-national.
Job Responsibilities
Provide support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
- Partners with other Departments to ensure that compliance systems are implemented in an efficient manner
- Carries out tasks (review and/or approval) related to the administration of site Change Control, Deviation and CAPA management systems
- Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate
- Supports system qualification and process validation activities
- Review and approval of qualification/validation documentation
- Carries out duties related to Supplier Assessment, Auditing and Inspection Readiness Systems at the site
- Participates in audits of second and third party suppliers and contractors
- Works with logistics team to ensure all supplier and materials are qualified
- Develops the raw materials and components specification and co-ordinates the approval of these specifications via the global process
- Reviews and/or approves all completed batch records in accordance with site procedures
KEY COMPETENCIES REQUIRED:
- Excellent interpersonal skills
- Ability to operate as part of a team is critical.
- Excellent communication skills both written and verbal
- Good problem solving skills
- Adaptable and flexible
QUALIFICATIONS AND EXPERIENCE:
- Bachelors Degree in a scientific/technical discipline required
- A minimum of 2 years experience in a quality, validation or compliance role within
the biological and/or pharmaceutical industry
- Knowledge of FDA/EMEA regulatory requirements applicable to biologics
and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and
international guidelines to all aspects of the position
- Demonstrated knowledge and application of industry regulations as they apply to
validation, including those of FDA, IMB, EMEA and other authorities
All applications will be treated with the strictest confidence
Kenny-Whelan Contact:
For further information please contact Carmel Egan on 021 4665405 or send your updated CV to cegan@kenny-whelan.ie