We are currently recruiting for a Qualified Person for our client, a pharmaceutical company based in Dublin. This is a full time role commencing in January for an 11/12 month contract.
MAIN DUTIES/RESPONSIBILITIES:
To ensure the quality management arrangements conform to the requirements of Marketing Authorisations, Manufacturers Licenses and current concepts and requirements of GMP
Responsible for carrying out Batch Certification as the Qualified Person as described in EU Directive 2001/83/EEC for products produced/tested under Baldoyles Manufacturers License and for products contract manufactured/packed in Ireland and from outside the EU
To ensure that effective documentation systems are in place
To ensure that adequate training programmes are in place
To supervise, in conjunction with the Quality Manager, both Customer and Regulatory Inspections at the company facility
To ensure compliance with the current Validation Policy and relevant legislative guidelines
To ensure all QC activities are in line with current guidelines
To carry out internal audits,
To carry out external audits as required
To undertake to work safely while on company premises
To maintain an up to date awareness of new legislative/guidelines that affect the job holders responsibilities and to ensure that this information is disseminated as appropriate
To provide assistance to the Quality Manager in the handling and investigation of complaints
To provide support to the Quality Manager in the event of product recall
Experience:
The successful candidate should have a Third Level qualification (Degree in Science or a related discipline) and Qualified Person status.
Minimum of two years experience as a practising QP.
For further information please call Ciara at 01 2784671 or email your CV in the strictest confidence to cbyrne@thornshaw.com .