Quality Assurance SME - Qualification & Validation

Summary:

We are recruiting a Quality Assurance SME - Qualification and Validation to join our project team to deliver a new state-of-the-art facility for API manufacturing team. This is a 12-month contract, and the position reports to the Quality Manager. The successful candidate will play a key role in the team delivering the project.

As Quality Assurance SME you will be the primary quality representative responsible for this project. You will be trusted to make quality relevant reviews, approvals and decisions as part of the project team, and you will do it 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 C&Q and Validation activities, Risk Assessments, Data Integrity, Change Control, Deviation, and other related quality system elements. Expertise in the GMP requirements for the qualification of process vessels and clean utilities is essential.

Responsibilities

• Ensure that quality standards are implemented on the project.
• Ensure compliance with quality and industry regulatory requirements.
• Provide professional and timely inputs/directions.
• Prepare data/reports to communicate outcomes of quality activities.
• Attend meetings (e.g., board/project/team meetings).
• Identify training needs and organize training interventions to meet quality standards.
• Reviewer/Approver of Change Controls, deviations, and GMP documentation.
• Reviewer/Approver of Qualification/Validation Documents (e.g., validations (master) plans/reports, (User) Requirement Specifications, 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.

Requirements

• Minimum qualification of a Bachelor's Degree in a scientific/technical discipline required.
• 5 years of 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.
• Can critically assess issues and devise and execute appropriate solutions using problem-solving techniques in a decisive manner.
• Strong business mindset.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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