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Quality Assurance Technical Engineer

PM GroupBaarle-Nassau, Noord-Brabant, Netherlands

2 dagen geleden

Functieomschrijving

PM Group is looking for a QA Technical Engineer to join a client team on a pharmaceutical site in Baarle-Nassau (Nl).

PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,600 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical / ICT, advanced manufacturing, energy and environmental sectors.

Our Vision is to be a highly valued and creative delivery partner, building a more sustainable world with our clients.

Our OTS (Outsourced Technical Services) department supports projects in different sectors on basis of project staffing with consultants working at the client’s site.

Responsibilities

The main focus of the Technical QA engineer is to provide support to the QA Operations organization with the review and approval of technical QA records and to represent client's Quality in the expansion project. This role acts as the main QA contact for commission, qualification and validation activities (eg user requirements, specifications of production & QC equipment, computerized systems, calibration equipment). The role is supporting the inclusion of the clients' requirements in regard to validation, qualification, maintenance, calibration and engineering into the client's quality system.

Support to the QA Operations organization with the review and approval of technical QA records. Specifically focused on commission, qualification, and validation activities.
Reviews and approves validation and maintenance protocols, reports and records for the production, warehouse / supply chain and QC department.
Reviews and approves Computerized System Validation (CSV) documentation.
Act as QA investigator to review deviations or OOX related to validation, maintenance, calibration, and technical production related issues. Ensures the root cause is determined, evaluate the impact on product quality and disposition of the batches.
Defines corrective and preventive actions linked to the records in scope of the functions and ensures timely implementation.
Reviews and approves changes related to the facility, computerized systems and production / QC equipment.
Performs QA oversight for validation and qualification activities for specific manufacturing and QC studies.
Acts as subject matter expert to develop, maintain and approve validation, qualification, maintenance and calibration procedures and ensures that site’s personnel is trained.
Supports during inspection preparation and acts as single point of contact for QA validation / calibration and maintenance during audits and inspections.

Qualifications

Bachelor's or Master's degree in a scientific area.

Fluent in English; Dutch would be an advantage.

3-5 years of experience in validation, maintenance, engineering or technical quality in a pharmaceutical cGMP or medical device environment.

Knowledge of cGMP for the defined area (commission & qualification activities, CSV in specific).

Analytical mindset and eye for detail.

Shows the appropriate sense of urgency.

Open and clear collaboration and communication skills.

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click HERE to read more in our ‘Corporate Responsibility and Health, Safety and Wellbeing Report’.

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