QA & Compliance Officer IMP Geleen • Basic Pharma

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 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!

We are looking for a 
QA & Compliance Officer IMP

• 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
• Carrying out self-inspections
• 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.
• Performing batch documentation reviews.
• 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 the QP where necessary
• Supporting other QA processes where desired
• Independently performing self-inspections (according to schedule and after consultation with the Director of Quality Affairs)
• Independently hosting customers
• Independently hosting customer audits
• Independently providing (GMP) training
• 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 of information relating to the above activities.
• Maintaining and reporting QA KPIs for the IMP/BPT department.

• 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.[RS1] 
• 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
• 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:

• We are constantly evolving
• 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.