- The Integrated Process Team (IPT) Pharma Outbound is divided into 2 parts: Pharma production and Outbound.
- The scope of Pharma Production contains:
- Production, testing and release of Pharmaceutical FPU (Finished Product Unpacked)
- Supporting activities: Planning, Maintenance & Reliability and Improvement
- Currently, we are looking for a Production Specialist level 2 for the Pharma Improvement team within the Pharma Outbound IPT.
- Reporting to the Improvement Lead, the Production Specialist plays a key role in ensuring that our products are manufactured in line with GMP guidelines and procedures.
- Supervise that the production processes in the IPT are executed in line with (GMP) guidelines, procedures and regulatory files.
- Act as Subject Matter Expert on product quality related issues and advise the Qualified Person on product quality impact due to changes/deviations in production processes.
- Evaluate consequences of external guidelines, as well as initiate and develop policies and procedures.
- Assess (incidental) deviations from approved policies and procedures and approve GMP related documents.
- Initiate and develop proposals / business cases for (Quality) improvement projects including deliverables and planning for the development and implementation of proposed improvements, in consultation with IPT staff, Quality and external parties
- Support the IPT regarding GMP inspections
- Monitor and analyze data (e.g. system and batch data, annual reviews, performance indicators), write or review data evaluation reports
- Possible task: SSO
- Project management role: Lead IPT-/site-wide projects
- Act as lead in cross functional investigations
- Affinity with MPS/Lean and ambition to develop
Desired skills & experience
- Bachelor or academic degree in life sciences
- More than 5 years experience in GMP/Quality related role
- Strong analytical and problem solving skills.
- Good interpersonal skills; personal leadership skills
- Result oriented, initiative, proactive, team player+
- Excellent oral and written skills in English and Dutch.
- Our company is working to help the world be well.
- Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals.
- We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them.
- Our company has a workforce of almost 4500 in the Netherlands at three main sites.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.