Quality Assurance SME – Qualification and Validation

Quality Assurance SME – Qualification and Validation

Industry: Active Pharmaceutical Ingredients (API)

Summary of Role: 

Quality Assurance SME to join the project team to deliver a new state-of-the-art facility for API manufacturing.

As Quality Assurance SME you will be the primary quality representative responsible for this project. You will complete quality relevant reviews, approvals and decisions as part of the project team via a constructive dialogue founded within a pragmatic understanding of the business’ needs.

You will manage compliance activities and Quality activities related to the project as required by Good Manufacturing Practice (GMP). These activities include, Compliance, Quality and Commissioning /Qualification /Validation activities, Risk Assessments, Data Integrity, Change Control, Deviation and other related quality system elements. Expertise in the GMP requirements for qualification of process of vessels and clean utilities is essential.

Role Responsibilities:

• Ensure that quality standards are implemented on the project.
• Ensure compliance with quality and industry regulatory requirement.
• Provide professional and timely inputs/directions.
• Prepare data/reports to communicate outcomes of quality activities.
• Attend meetings as required.
• Identify training needs and organize training interventions to meet quality standards.
• Reviewer/Approver of Change Controls, deviations, GMP documentation.
• Reviewer/Approver of Qualification/Validation Documents (e.g., validations (master) plans/reports, URS, DQ, IQ, OQ, PQ, PPQ/PV, RCL, RTM, risk assessments, SOPs).
• QA oversight of qualification and validation activities on the project.
• Follow Local EHS procedures.

Education and Experience:

• Minimum qualification of a Bachelor’s Degree in a scientific/technical discipline required.
• 5 years experience working with quality and cGMP in the pharma industry.
• Experience in C&Q and life cycle qualification/validation support.
• Skilled in the execution of Risk Assessment and in the use of a variety of problem-solving techniques.
• Experience in the current Quality and regulatory standards by EudraLex etc.
• Enjoy working closely with your stakeholders and have a hands-on operational approach to Quality.
• A good communicator and when collaborating on a given task you contribute with a positive and constructive attitude.
• Work independently with a strong personal drive.
• Strong attention to detail and excellent organisational skills.
• Have the ability to critically assess issues and devise and execute appropriate solutions using problem-solving techniques in a decisive manner.
• Strong business mindset

Duration: 1 year

Location: Cork