Production Quality Specialist

Amsterdam area
4000.00 - 6000.00
32-40 hours
Direct hire by client
Bachelor degree

Client

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

Requirements

Education Level:

Academic working and thinking level (Master's degree level or equivalent).
Preferably in Pharmacy, Chemical Engineering, or a related field.

Knowledge and Experience:

Knowledge of (aseptic) pharmaceutical processes.
Knowledge of production control systems.
Knowledge of quality assurance systems.
Experience within the pharmaceutical industry in a production environment.

Skills:

Communication skills.
Advisory and consultative skills.
Proficiency in spoken and written English.
Analytical skills.
Planning and organizational skills.-
Writing and reporting skills.
Ability to perform effectively in a dynamic and demanding environment.
Knowledge transfer and training skills.

Competencies / Attitude:

Results-oriented.
Understanding of causes and consequences.
Team player.
Technical/professional expertise.
Collaboration and influencing skills.

What do you get?

Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
Collective WGA / WIA insurance
NBBU collective labour agreement through equal remuneration
25 holidays days
8% holiday allowance
100% payment in case of illness in the first year
Travel allowance per kilometer or through public transport

Duties

Purpose:
To evaluate and contribute to the realization of pharmaceutical production in accordance with the guidelines established by the Operations Business Unit.

Duties and Responsibilities:
1. Responsible for quality assurance within production, including:
Ensuring the improvement, support, assessment, and control of activities related to pharmaceutical production (bulk manufacturing and packaging).
Key Activities:

Supporting production with deviations and quality-related issues.
Assessing and deciding whether production activities should be halted as a result of a deviation.
Making proposals to improve production methods and products, and implementing developments in production technology.

2. Providing content-related and technical support to the Business Unit regarding quality issues and improvement initiatives.
Key Activities:

Monitoring and reporting on production processes and any deviations from established procedures.
Investigating and documenting identified deviations and complaints.
Performing and documenting root cause investigations and CAPAs (Corrective and Preventive Actions).
Developing, initiating, and implementing improvement proposals resulting from production deviations, internal and external audit observations, or as part of continuous improvement initiatives.
Making recommendations regarding occupational health and safety, product safety, and environmental matters.
Participating in various projects aimed at improving quality-related aspects.
Supporting compliance investigations and audit responses.

3. Implementing and maintaining company quality standards and GMP instructions, and ensuring adequate documentation and protocol compliance.
Key Activities:

Reviewing SOPs, production and validation protocols, batch manufacturing records (BMRs), and related documentation.
Participating in and contributing to projects, change controls, CAPAs, and similar initiatives.
Providing knowledge transfer and delivering training.