Senior QA Associate

Desired Skills: quality assurance,GMP,operations,CAPA

Description:

PE Global is currently recruiting for a Senior QA Associate on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

This is a shift position.

The shift patterns are as follows: 07:00 to 19:00, and 19:00 to 07:00. (4 on, 4 off).

Overview:

• The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team.
• As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.
• This is a 24/7 shift role required to support manufacturing operations.

Role Responsibilities:

• Ensure adherence to safety standards and SOPs in all activities.
• Review and approve production batch records and associated documentation for Qualified Person disposition activities.
• Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
• Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
• Offer Quality Assurance support for on-the-floor investigations and deviations.
• Review and approve deviations for closure, ensuring compliance with appropriate documentation.
• Participate in customer complaint investigations.
• Conduct routine Quality Assurance walks on the production floor.
• Review and issue logbooks, ensuring compliance with procedures.
• Provide training and guidance to staff for effective performance.
• Review and approve cGMP records, ensuring compliance with appropriate documentation.
• Support continuous improvement and Operational Excellence initiatives.

Skills required:

• Minimum Qualification: Science Degree /Engineering degree
• Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
• Excellent written and verbal communication skills.
• Experience working with dynamic cross-functional teams and proven abilities in decision making.
• Strong organizational skills, including ability to follow assignments through to completion.
• Demonstrated ability in problem solving particularly in supporting non-conformance/deviation investigations.
• Experience working in aseptic operations, protein formulation, vial and syringe filling.
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

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***