Qa Officer Compliance vacatures in de provincie Limburg

QA & Compliance Officer

Summary Apply

Questions about this vacancy?

Please contact our HR department at

+31 (0)88 255 40 10

.

Our company

Basic Pharma is a unique Dutch pharmaceutical company that is growing rapidly, continuously building its organization and increasingly specializing and developing. The company focuses on the entire spectrum of the pharmaceutical industry: from product development, registration, production and commercialization of (bio)pharmaceutical products to pharmaceutical services. Basic Pharma serves an ever-growing circle of national and international customers, from start-ups to multinationals.

The production organization Basic Pharma Manufacturing manufactures products such as nasal sprays, pre-filled syringes, creams and ointments. It also supplies study medications (IMPs) and offers various services to third parties, such as quality control and contract manufacturing.

Basic Pharma Technologies develops pharmaceutical products for its own production organization, often in collaboration with partners, and then licenses these to customers. This business unit now also has a biotech facility for product development and study medications.

Finally, Interdos has built up a solid track record in providing advice and consultancy services in the areas of Regulatory, Pharmacovigilance and Quality.

The availability and combination of all these activities under one roof makes Basic Pharma a strong and versatile player within the pharmaceutical industry. Currently, there are approximately 250 employees. Basic Pharma's ambitions continue to grow, which is why we are looking for employees who are committed, value professionalism highly and put the customer first. Does this appeal to you? Then the vacancy below may be just the thing for you!

Responsibilities:

• Ensuring that products and manufacturing processes are fully compliant with current standards and legislation and regulations
• 'QA Voice on the floor': first point of contact for quality-related matters on the IMP production floor
• Reporting and escalating (quality) issues
• Monitoring the correct follow-up of processes regarding the registration and handling of quality issues and changes
• Monitoring the correct implementation of GMP-related processes for recording and handling these issues
• Timely and accurate recording, reporting and archiving information relating to the above activities
• Maintaining and reporting QA KPIs for the IMP/BPT department.

What do you bring to the table as a QA & Compliance Officer IMP?

• At least 5 years of experience in a quality-controlled production environment (GxP, HACCP and/or ISO)
• Knowledge of EU GMP and ICH guidelines
• High degree of independence
• Good knowledge of English, both spoken and written. Dutch is an advantage.
• Thorough knowledge of Windows, Word and Excel.
• Good communication skills (for colleague and customer contact)
• You are diplomatic, but certainly persuasive in an assertive manner
• You are a team player
• You have technical affinity, problem-solving skills and project management skills
• Goal-oriented, proactive and pragmatic
• (At least) HBO (higher professional education) level of working and thinking
• Experience with quality systems, preferably in the pharmaceutical industry
• A technical/engineering/physics/biomedical education is an advantage