QA Specialist

The role:

PE Global is currently recruiting for a QA Specialist on behalf of a leading API company based in Tipperary. This is an initial 11-month contract role. This is a hybrid working role – 1 day per week onsite.

Purpose:

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

Responsibilities:

• 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.

Education and Experience:

• Bachelor’s degree in a Science or Engineering discipline
• 3+ years quality experience in a regulated industry

• Must have good communication skills, both written and verbal.
• Must be motivated, focused and technically strong.
• Team and interpersonal skills

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***