QA & Compliance Officer

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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!

Providing QA support for the introduction of new products and processes within the IMP department

Registering and supporting/reviewing changes and root cause investigations in response to deviations, CAPAs, OOSs and complaints

Keeping track of developments within the field and in legislation and regulations and identifying bottlenecks within the IMP/BPT department.

Implementing, maintaining and continuously improving the QMS system in accordance with these standards

Advising and supporting changes to protocols, procedures and work instructions

Providing QMS training to IMP/BPT employees

Independently organizing and supervising customer audits, including reporting and monitoring follow-up

Monitoring progress in the handling of product and production-related quality issues.

Guiding and performing process and product risk assessments

Monitoring and timely reporting of approaching deadlines for quality issues and changes

Supporting the review of change control documentation

Measuring (KPIs) and optimizing processes by setting up QA workflows with process owners

Supporting other QA processes where desired.

Independently performing self-inspections (according to schedule and after consultation with the Director of Quality Affairs)

Addressing (IMP/BPT) colleagues about quality issues

Proactively initiating improvement proposals

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)

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 have technical affinity, problem-solving skills and project management skills

(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

Basic Pharma offers a challenging position with excellent terms of employment in a dynamic and inspiring working environment:

Working in a team of enthusiastic colleagues

We encourage our employees in their development by offering (internal) courses and training

Acquisition in response to this vacancy is not appreciated.

Why are you the right person for this position? We look forward to your motivation and résumé!