Quality Assurance Specialist

Ref. no.: JO-1201-240475B

Tags: quality assurance qa compliance

Location(s): Cork Tipperary Waterford

Salary range (€): Negotiable

Additional benefits: Canteen

Minimum experience required: 3 - 4 Years

Employment type: Permanent Full-time

Minimum qualification: No Minimum required

Contact person: Aileen Cahill

Contact e-mail: aileen.cahill@cpl.ie

Job description:

Quality Assurance Specialist

My client a leading pharmaceutical company based in Tipperary is looking to recruit for a Quality Assurance Specialist


Reporting to the Head of Quality the role will involve:

· Assess compliance systems on ongoing basis to identify opportunities for process improvement
· Ensure quality issues are communicated to the management team such that they are aware of any significant variance from targets or potential opportunities or problems.
· Ensure efficient Regulatory and Change Control procedures exist and are implemented to ensure compliance with product licenses.
· Ensure preparation and approval of RXIL Product Quality Reviews is conducted in a timely manner.
· Co-Ordinate RXIL and MA Holder reviews of RLL Product Quality Reviews.
· Ensure qualification of selected vendors and manage on- going vendor quality performance.
· Schedule and perform Supplier audits (Printed packaging material, API's, contract laboratories, warehouses, manufacturers etc).
· Ensure that internal audit of all six quality sub- systems at sites are conducted as per schedule and audit findings are addressed in a timely manner
· Coordination of vendor complaints and ensure timely and satisfactory resolution of same.
· Provide a supporting role during supervising authority (IMB), corporate and customer audits.
· Prepares and provides training in GMP to all site personnel.
· Maintain the Quality Systems in place.

Skills and Education

· 5 years experience in pharmaceutical quality or compliance roles, inclusive of implementing and maintain site operations and activities in line with regulatory requirements
· BSc. Degree in Chemistry, Pharmacy or relevant scientific field.

Suitable applicants should email their cv to the above email address or call 01-6146007 for a confidential conversation.