QA Specialist

Desired Skills: complaints,deviations,release of goods

PE Global are currently recruiting for a QA Specialist for our client site in Tipperary:

11 month initial contract

The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities at he Ballydine site.

Responsible for the release of incoming goods, products for which production or packaging is outsourced, and products and processes in full compliance with quality procedures, legal guidelines, quality guidelines and market authorization.

Responsible for advice on and improvements of quality related issues, in order to ensure an optimal quality of released products and processes.

Will understand the quality requirements for the introduction of materials to site, will have the capability to communicate the requirements to suppliers and will use good documentation practices and be capable of implementing these at a local level.

Works with moderate work direction and is skilled and knowledgeable to the position.

Key Result Areas and Primary Activities

• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• Creates and maintains assigned SOPs.
• Compiles data for reports and presentations, provides data interpretation draws conclusions.
• Completes audits to ensure compliance to SOPs, GMPs and applicable regulations.
• Support product recalls and stock recoveries as appropriate.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
• Identify compliance gaps and make recommendations for continuous improvement
• Assists in the induction process for new starters and training of other staff.
• Generally, follows standard procedures and consults with manager/supervisor on exceptions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance
• with Company and regulatory requirements.
• Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
• Represents department on cross functional teams.
• Additional activities as assigned by the manager/supervisor

• Skills Required
• The Specialist is required to possess a degree in an Science or Engineering discipline plus some industrial experience.
• Alternatively, they must possess considerable industrial experience.

 Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 021- 4297900 or alternatively send an up to date CV audrey.mccarthy@peglobal.net